• Perform environmental monitoring in ISO Class 5,6,7, & 8 environments.
• Support microbiology laboratory operations.
• Investigate and troubleshoot equipment, testing, and process abnormalities.
• Perform biological assays of raw materials, in-process samples, and drug product.
• Prepare and present data summaries.
• Accurately document all necessary and relevant information clearly and concisely per cGMPs.
• Author, revise, and review standard operating procedures, test methods, work instructions, and protocols.
• Maintain a clean, orderly, and safe laboratory work area.
• Assist in the development of microbiological laboratory testing procedures.

Skills: Environmental Monitoring, Microbiology Support, Equipment Troubleshooting, Biological Assays, Data Summaries, cGMP Documentation, SOP Management, Laboratory Safety

• Provide functional support for biotech molecules and facilities.
• Serve as a pivotal point of contact with QCL (Quality Control Labs) Microbiology.
• Provide on-the-floor microbiological support for manufacturing, such as ensuring Sani logs and VWA are current and correctly located.
• Partner with Operations, QC Analytical Microbiology, Technical Scientists, Engineering, and Quality to support daily operations.
• Demonstrate aptitude and interest in data accrual and evaluation.
• Analyze and report data while ensuring all aspects of data integrity are maintained at all times.
• Maintain functional GMP Documentation such as SOPs, microbial protocols, reports, trend analyses, clean utility records, and EM monthly meeting minutes.
• Ensure all documentation remains accurate, current, and compliant with established quality standards.

Skills: Biotech Support, Microbiology Liaison, Manufacturing Floor Support, Cross-Functional Collaboration, Data Evaluation, Data Integrity Reporting, GMP Documentation, Quality Compliance

• Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release.
• Perform and document environmental monitoring of the facilities and water systems in compliance with Standard Operating Procedures, for cross-functional support.
• Maintain environmental monitoring trend data to drive continuous improvements, identify trends, and draw conclusions.
• Provide support to the facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions.
• Complete environmental monitoring and laboratory-related investigations, and properly document results.
• Perform LAL, water analysis, growth promotion, Gram staining, identification of microorganisms, and other microbiological testing
• Perform and document environmental monitoring in compliance with Standard Operating Procedures.
• Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
• Maintain laboratory instrumentation required for testing and cleanliness of the laboratory per SOP guidelines.
• Maintain and track assigned testing activities to completion.
• Assist in the review of test data and report any deviations to the supervisor.
• Assist management in writing/updating Standard Operating Procedures (SOPs)
• Participate in projects involving the Quality Control and/or Microbiology departments
• Train team members in microbiology and chemistry laboratories
• Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.

Skills: Microbiological Testing, Environmental Monitoring, Trend Analysis, Nonconformance Support, Laboratory Investigations, Microbial Identification, GMP/GLP Documentation, Instrument Maintenance

• Support the Laboratory Research Operations team by assisting in the management and biobanking of a proprietary microbial strain collection.
• Work with and without automated platforms to assist in strain propagation, collection reformatting, and archival.
• Assist in the maintenance of the strain collection through solid and liquid bacterial strain propagation of genetically diverse non-pathogenic soil microorganisms.
• Maintain accurate records and database entries for all strain tracking and traceability.
• Work closely with biosafety level 1 and 2 microorganisms according to external and internal biosafety guidelines.
• Assist in the management of the internal microbial strain collection.
• Perform strain retrieval and propagation to support replication and reformatting efforts.
• Collect and compile data and records in laboratory notebooks and documentation systems to ensure sample tracking and chain-of-custody records are maintained.
• Propagate microorganisms in solid and liquid formats.
• Help determine the appropriate medium under guidance to ensure microbial growth and sporulation.
• Perform cryopreservation of microorganisms using best practices to support long-term storage stability and survivability.
• Leverage robotics and standard laboratory equipment to execute tasks.
• Comply with BSL-2 level biosafety guidelines.
• Collaborate with the team to ensure operational efficiency and quality through adherence to standard operating procedures.
• Follow protocols consistently to maintain accuracy, safety, and workflow continuity.

Skills: Microbial Strain Management, Strain Propagation, Biobanking Operations, Data & Sample Traceability, Biosafety Compliance, Cryopreservation, Robotics-Assisted Processing, SOP Adherence

• Comply with legislative requirements for construction projects.
• Comply at all times with Health, Safety, and Environmental policy and Quality Compliance.
• Ensure all work is carried out in compliance with GMP, GLP, and regulatory standards and guidance.
• Ensure all work is documented in accordance with the highest GMP standards, including maintenance of data integrity at all times.
• Assist with the introduction and validation of all Microbiology methods in-house, including Environmental Monitoring, Identifications, Growth Promotion, Sterility, Endotoxin rapid method, Microbial Limit Testing, and Biological Indicators.
• Provide technical knowledge and guidance on aseptic assurance, sterility assurance, and trending to the production environment for the duration of the project and during routine operation.
• Participate in Operational Readiness for the duration of the project.
• Participate in risk assessments.
• Assist in the provision of oversight during Media Fills.
• Provide support and backup to the Senior Microbiologist and take on delegated tasks and projects.
• Maintain adherence to all applicable procedures to ensure quality and compliance.
• Support project activities by applying microbiological expertise throughout all phases.

Skills: Regulatory Compliance, HSE Adherence, GMP/GLP Standards, Method Validation, Aseptic Assurance, Risk Assessment, Media Fill Support, Microbiology Project Support

• Perform environmental and utility monitoring and sampling as a primary function.
• Perform routine and non-routine inspection of media fill samples, collection and testing of media, final product, validation-related samples, and critical utility samples according to SOPs.
• Receive, quarantine, and store purchased microbiological media pending laboratory release.
• Monitor biohazardous waste and coordinate its removal with qualified safety personnel.
• Participate in validation and commercial or developmental manufacturing activities.
• Review and issue Environmental Notifications based on raw data and validated electronic data acquisition systems.
• Represent QC for the area of specialization in site meetings.
• Support testing of solid oral dosage forms, packaging components, raw materials, and sterile products.
• Troubleshoot standard instrumentation and test methods.
• Perform activities in support of final product release testing, including assays for endotoxin, sterility, and particle isolation.
• Perform activities in support of raw material testing, including media growth promotion.
• Perform activities in support of environmental monitoring, including surface viable air, non-viable air, and personnel monitoring.
• Perform activities in support of bioburden testing of water and product.
• Perform viable and non-viable particle testing.
• Perform moisture testing of compressed gases and air to support quality operations.

Skills: Environmental & Utility Monitoring, Sample Testing, Media Management, Biohazard Oversight, Validation Support, QC Representation, Instrument Troubleshooting, Final Product Testing

• Carry out a complex scope of interdisciplinary assignments and possess key expertise in the area of microbiological and molecular techniques, equipment, and methodologies.
• Perform microbiological and molecular testing to support functional areas of focus, which may include method development and validation initiatives, crossovers, and product qualifications.
• Exercise technical discretion in the design, execution, and interpretation of data, making detailed observations and extrapolating logical scientific conclusions with minimal supervision and direction.
• Implement new technologies.
• Serve as a technical contributor and manage whole or major parts of project plans, programs, and work supporting various customers.
• Serve as a key technical resource and analytical problem solver within the Global Microbiology Group and the company overall.
• Conduct internal and external training and assessments, including on-site visits.
• Identify, evaluate, develop, and implement methods and technologies as the need arises.
• Work with Global Microbiology Management and the team to align resources needed to complete project objectives.
• Contribute to overall strategic and operational plans for the Global Microbiology Group and serve as an active participant who consistently contributes to the continuous improvement of lab operations.
• Maintain relationships and programs with contract, governmental, or academic labs.
• Operate, maintain, and advanced troubleshoot laboratory equipment.
• Perform general laboratory operation and maintenance, including glassware handling, waste disposal, reagent preparation, inventory management, shipping, and receiving.
• Prepare technical reports, summaries, protocols, presentations, and quantitative analyses.

Skills: Microbiology Expertise, Method Development, Data Interpretation, Tech Implementation, Project Leadership, Problem Solving, Training Support, Equipment Troubleshooting

• Perform processing and analysis of environmental samples to detect potential biological threat agents.
• Assist with the in-processing of samples to ensure proper documentation and workflow continuity.
• Support DNA preparation activities by following established laboratory procedures.
• Contribute to immunoassay tasks by preparing materials and performing required steps under guidance.
• Participate in PCR analysis to help identify the presence of targeted biological materials.
• Enter sample and test data into the laboratory information management system with accuracy.
• Update information in the sample management system to maintain complete and organized records.
• Carry out general laboratory housekeeping duties to support a clean and efficient working environment.

Skills: Environmental Sample Analysis, Sample Processing, DNA Preparation, Immunoassay Support, PCR Assistance, LIMS Data Entry, Record Maintenance, Lab Housekeeping

• Perform key routine procedures in a microbiology laboratory with supervision according to established SOPs, including water testing, bioburden testing, and environmental monitoring.
• Perform key non-routine procedures with supervision following established SOPs, including organism identification, SOP revision, and failure investigation.
• Prepare reports, e-mails, and memos tailored to a defined audience as directed by the supervisor.
• Support the administration of laboratory systems such as safety, calibration, documentation, and inventory.
• Participate in receiving and providing cross-training on required SOPs, technical procedures, and safety practices.
• Conduct laboratory tasks in compliance with quality and safety standards set by internal guidelines.
• Contribute to troubleshooting efforts by documenting findings and communicating observations to supervisors.
• Assist in maintaining organized laboratory records to ensure traceability and regulatory readiness.
• Collaborate with team members to promote consistent application of laboratory procedures.
• Engage in continuous learning to enhance proficiency in laboratory operations and technical skills.

Skills: Water & Bioburden Testing, Environmental Monitoring, Organism ID, Report Preparation, Lab Systems Support, Cross-Training, Troubleshooting Support, Record Management

• Review wash times and water usage with a critical approach and identify opportunities for continuous improvement.
• Verify wash and sanitisation procedures for fillers to ensure effective cleaning outcomes.
• Confirm that the wash and sanitisation steps for manufacturing vessels meet established hygiene expectations.
• Verify wash and sanitisation processes for ancillary product contact equipment to maintain compliance.
• Serve as an expert resource to support the resolution of hygiene-related incidents.
• Contribute expertise during quality risk assessments that involve hygiene or cleaning controls.
• Guide teams to promote consistent adherence to hygiene standards.
• Document findings and recommendations to support ongoing quality improvements.
• Collaborate with colleagues to address challenges related to cleaning and sanitisation activities.
• Assist the Head of Quality with tasks required to support the efficient operation of the Quality Department.

Skills: Wash Process Review, Sanitization Verification, Hygiene Compliance, Incident Support, Risk Assessment, Hygiene Guidance, Quality Documentation, Quality Support

• Maintain data integrity and employ good documentation practices when performing experiments.
• Compare laboratory data against specifications and trend data to determine if results meet requirements.
• Ensure proper usage, care, and return of calibration standards, including reference standards, timers, thermometers, and instrumentation.
• Ensure accuracy of testing by following the method and standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations.
• Perform primarily routine testing for microbial examination under general supervision in support of pharmaceutical excipients, API, and drug products.
• Test purified water systems, perform microbial limits testing, particulate matter analysis, water activity measurements, and environmental monitoring.
• Enter data into established reports, templates, or software-based systems.
• Conduct a peer review of basic laboratory experiments and ensure accuracy of the testing procedure.

Skills: Data Integrity, Spec Comparison, Calibration Handling, Method Adherence, Routine Micro Testing, Water & EM Testing, Data Entry, Peer Review

• Conduct testing under compendial methods such as BAM, CTFA, SMWW, USP, and internal SOPs.
• Operate balances, autoclaves, pH meter, stomacher, pipette aid, while using aseptic technique.
• Complete necessary documentation in associated logbooks and data collection sheets.
• Ensure that incoming samples are properly tested and documented.
• Participate in client and internal microbiological studies and special projects.
• Follow guidelines for a safe work environment in a cGMP-FDA, regulated environment according to OSHA Laboratory Standards.
• Support the timely execution of equipment maintenance, calibration, and documentation.

Skills: Compendial Testing, Aseptic Operation, Documentation Accuracy, Sample Processing, Study Support, Safety Compliance, Equipment Maintenance, Calibration Support

• Undertake the microbiological analysis of raw materials, intermediate bulks, finished products, stability samples, water samples and environmental monitoring within a fast-paced Quality Control environment.
• Review the analysis completed by others, and facilitate corrections/amendments.
• Identify and facilitate the update of methodologies and best practices.
• Perform weekly water sampling and testing (testing to include description, specific conductivity, TOC, total coliforms, and aerobic plate count).
• Prepare media, keep track of microbiological inventory and organisms, and use the autoclave.
• Initiate Anomalous reports, OOS forms, Deviations, Change Controls, and Effectiveness Reviews for related work.
• Contribute to the development of the department and individuals through coaching, mentoring, and formal training.
• Write, review, and revise SOPs.
• Perform physical testing on QC samples.
• Support the QC Supervisor and Chemists, as directed in the execution of their duties.
• Abide by and champion the company's values (Dedication, Enjoyment, Courage, Honesty, Ambition) in all aspects of the role, including interaction with co-workers and third parties.

Skills: Micro Analysis, Data Review, Method Updates, Water Testing, Media Prep, Quality Reporting, Training Support, SOP Management

• Perform accurate microbiological testing of raw materials, in-process samples, and finished products, including stability/stress testing, using instrumental and physical analytical methods and techniques.
• Document, review, evaluate, and investigate analytical results, including the reporting and investigation of deviating results.
• Report all observations and data on time, meeting specified deadlines.
• Independently conduct validation studies and microbiological and analytical/ QA work required to support them.
• Participate in QA/QC method development and improvement work.
• Supportive product complaint, chemical, and analytical/QA work.
• Adhere to established, validated methods and company procedures in performing all tests.
• Adhere to cGMP, Good Laboratory Practices, and other regulatory procedures.
• Assist in the creation, review, and approval of Tower’s various QA/QC and technical documents regarding SOPs, validations, operations, and other QC/R&D studies.
• Assist in the instruction and training of QA/QC and other technical personnel.
• Conduct laboratory housecleaning and upkeep, assist in retaining storage and distribution to promote a safe and orderly work area that customers will view as a representation of a quality operation.
• Observe and practice all company safety procedures in performing duties.

Skills: Micro Testing, Data Evaluation, Timely Reporting, Validation Studies, Method Development, QA Support, SOP Management, Training Assistance

• Validate and develop microbiological methods for testing of raw materials, finished goods, and R&D samples with moderate to minimal supervision.
• Follow all procedures related to data documentation, laboratory safety, and good laboratory practices.
• Review test data, calculations, and results for accuracy and completeness.
• Use laboratory instrumentation and computer systems to collect and record data, identify malfunctions in laboratory equipment, and advise the supervisor or perform simple repairs.
• Initiate OOS, OOCAL, and Deviation investigations under supervision.
• Continue to build knowledge of the organization, products, processes, and customers.
• Use prescribed guidelines or policies to analyze and resolve problems.

Skills: Method Validation, GLP Compliance, Data Review, Instrument Operation, Issue Investigation, Equipment Troubleshooting, Problem Analysis, Process Knowledge

• Develop and review microbiological and analytical methods and procedures for water quality analysis.
• Perform complex microbiological testing and evaluate the effectiveness of testing methods.
• Comply with the requirements of the Laboratory Quality Management System.
• Maintain all required documentation and conduct Standard Operating Procedure review and updates.
• Sample collection, receiving, login, preservation, and shipping.
• Participate in the proficiency testing program and monitor the performance of work performed in the Microbiology section through the internal audit program.
• Perform routine and non-routine maintenance of laboratory equipment and instruments.
• Data reporting, review, and trend analysis using the Laboratory Information Management System.

Skills: Method Development, Micro Testing, LQMS Compliance, SOP Management, Sample Handling, Proficiency Testing, Equipment Maintenance, Data Analysis

• Support all activities related to the microbiological assessment of products and the manufacturing environment.
• Advise Quality Assurance, Manufacturing, and R&D departments on matters related to product sterilization and microbial assessment.
• Evaluate the operation of Manufacturing and Quality Assurance activities in relation to sterilization compliance with quality standards and regulations, and recommend where corrections or improvements are indicated.
• Supports root cause analysis for nonconformity and/or out-of-specification events.
• Provide direct support to Quality Assurance personnel regarding the operation of the department and Quality System.
• Assist in assessing the impact of manufacturing-related changes on the sterilization and cleanliness attributes of finished products.
• Help manage and execute microbiological and chemistry testing.
• Conduct work in compliance with cGMP, safety, and regulatory requirements.
• Provide analysis and evaluation of materials and products at all stages of the development process.

Skills: Micro Assessment, Sterilization Guidance, Compliance Evaluation, Root Cause Support, QA Support, Change Impact Review, Testing Execution, Regulatory Compliance

• Research bacteria and phages in situ or in plant assays.
• Plan and perform experiments using a variety of microbiology techniques.
• Record, analyze, and interpret data.
• Plan experiments based on processing and conclusions.
• Design new methods according to the literature.
• Adhere to testing and project deadlines as assigned by quality laboratory management.
• Adhere to 5S standards in the laboratory.

Skills: Bacteria Research, Experimental Planning, Data Analysis, Method Design, Deadline Adherence, 5S Compliance, Micro Techniques, Project Execution

• Apply high-quality scientific techniques in the microbiological analysis of raw ingredients, in-process production samples, finished product testing, and environmental monitoring to ensure that all products manufactured are fit for use.
• Work with fellow microbiologists with a high degree of motivation and attention to important details, providing clear communication to all team members due to the high degree of responsibility and reliance within a small group.
• Prioritize tasks to be completed efficiently with the most accurate results and communicate clearly while working together in a team environment.
• Perform product testing, environmental testing, and raw ingredient testing.
• Perform documentation, project work, and troubleshooting.
• Perform media preparation and general lab work, including housekeeping.

Skills: Micro Analysis, Team Collaboration, Task Prioritization, Product Testing, Documentation Work, Troubleshooting, Media Prep, Lab Housekeeping

• Coordinate and perform routine microbial testing of finished product, bulk in process, raw material, stability, and PET samples on the second shift in accordance with compendial and in-house methods, and perform analytical testing.
• Prepare stock cultures, media, plates, standards, and solutions needed for microbiological testing.
• Develop and perform environmental monitoring functions.
• Ensure effective utilization of equipment over multiple shifts to allow flexibility and added capacity.
• Order and maintain the chemical and consumable material inventory necessary for microbial testing.
• Perform routine maintenance, cleaning, and calibration of equipment used in the microbiology laboratory.
• Perform general housekeeping and organization of microbial workspaces according to GLP standards.
• Perform routine physical and chemical testing of finished product, bulk in process, raw material, and stability samples in accordance with compendial and in-house methods.
• Recommend and initiate testing protocols for special microbiological projects in support of R&D.
• Perform peer review of analytical and microbiological notebooks, logbooks, and other documents.

Skills: Microbial Testing, Media Prep, Environmental Monitoring, Equipment Utilization, Inventory Management, Equipment Maintenance, Physical/Chemical Testing, Document Review

• Oversee the proper upkeep and maintenance of test equipment, instruments, sterilized supplies, and the laboratory environment.
• Maintain routine QC microbiological cultures.
• Interface with customers on sample submissions, job status, and technical inquiries.
• Ensure compliance with laboratory quality management and safety guidelines.
• Serve as an entry-level microbiologist providing laboratory assistance to senior investigators addressing microbiological research priorities.
• Perform varied but routine and limited scientific microbiological analyses and tests on samples submitted to the field laboratory.
• Participate in firm inspections with experienced investigators or regulatory scientists in a training capacity.
• Prepare scientific reports and record in detail the receipt, handling, and analysis of samples.

Skills: Equipment Maintenance, Culture Management, Customer Support, Quality Compliance, Lab Assistance, Micro Testing, Inspection Support, Report Preparation

• Conduct a wide range of traditional and novel microbiological tests, undertaking multiple pieces of work in parallel to support internal and external stakeholder requirements and generate results within agreed deadlines.
• Participate in the introduction and testing of novel microbiology techniques aimed at monitoring and enumeration microorganisms.
• Plan and contribute to a practical programme of work within materials protection, technical service, and application development areas.
• Work as part of the team to support colleagues and perform all activities safely in accordance with internal quality standards, EHS requirements, and COSHH regulations.
• Produce and maintain accurate results and reports within the Biocides Information Retrieval Database to agreed standards.
• Execute existing protocols and literature precedents to meet customer needs and support new materials protection applications and products.
• Monitor and organise service contracts for equipment to ensure regular maintenance and servicing for safe and timely laboratory operations.

Skills: Micro Testing, Novel Techniques, Work Planning, Team Safety, Data Reporting, Protocol Execution, Equipment Oversight, Materials Support

• Own documentation in support of manufacturing environments at the Rice Creek facility.
• Support cleanroom qualifications and re-qualifications.
• Trend and determine limits for inputs used in environmental monitoring data.
• Investigate and own environmental excursions and nonconformances.
• Participate in internal and external audits as the site expert on manufacturing environments.
• Assess changes to manufacturing environments and utilities.
• Schedule environmental monitoring testing with internal and external vendors.

Skills: Documentation Ownership, Cleanroom Qualification, EM Trend Analysis, Excursion Investigation, Audit Support, Change Assessment, EM Scheduling, Vendor Coordination

• Provide expert-level applied knowledge and in-depth understanding of microbiological techniques, including sterility, endotoxin, environmental monitoring, organism identification, and contamination control strategies.
• Provide technical leadership and expertise for QC Microbiology studies and projects.
• Lead and conduct risk assessments for aseptic operations and contamination control.
• Establish and implement appropriate training programs in collaboration with training leads.
• Harmonize policies, practices, and procedures across CAR T sites globally.
• Create, review, and approve microbiological studies, procedures, test methods, protocols, reports, and related QC Microbiology documentation.
• Provide training to QC Microbiology staff to ensure testing activities are performed efficiently and in compliance with cGMP requirements.

Skills: Micro Technique Expertise, QC Leadership, Risk Assessment, Training Programs, Policy Harmonization, Document Approval, Staff Training, Contamination Control

• Develop advanced expertise in the regulatory requirements to place registered biocide products on the European markets (Biocide/Detergent/CLP legislation).
• Interpret microbial efficacy (i.e., bacteria, virus, fungi tests), stability (i.e., analytical chemistry), and safety data (e.g., foodborne pathogens, dietary assessments, skin and eye safety.
• Provide effective product stewardship while maintaining compliance.
• Integrate the data and the regulatory requirements to develop guidance on possible claims and expand related marketing opportunities as much as possible.
• Integrate the regulatory requirements into an actionable business guidance to enable the R&D Home Care categories to develop compliant biocide products.
• Lead and optimize deliverables of the P&G biocide registration office.
• Interpret the regulatory status of biocide products on the market.

Skills: Regulatory Expertise, Efficacy Interpretation, Product Stewardship, Claim Guidance, Compliance Integration, R&D Support, Registration Leadership, Market Assessment

• Provide essential microbiological analytical laboratory services for food and beverage manufacturers, private sector clients, commodity exporters, and the broader food industry in line with Element’s standards.
• Maintain accurate records of all performed procedures to support the implementation of ISO/IEC 17025:2005 in the laboratory.
• Maintain good laboratory housekeeping and ensure adherence to Health, Safety, and Environment standards.
• Perform all analytical testing for samples and record and update results in the LIMS system.
• Set up tests, perform read-outs, and maintain area sanitation to meet client microbiology requirements within short hold time frames.

Skills: Micro Lab Services, ISO Recordkeeping, Lab Housekeeping, HSE Compliance, Analytical Testing, LIMS Entry, Test Setup, Area Sanitation

• Perform and review sample analysis using analytical methods.
• Perform in-house instrument calibration and serve as equipment subject matter expert.
• Conduct training on cGMP and general laboratory guidelines for new employees.
• Conduct reviewer training.
• Conduct test method training and equipment briefings.
• Perform necessary analytical laboratory activities.

Skills: Sample Analysis, Instrument Calibration, Equipment Expertise, cGMP Training, Reviewer Training, Method Training, Lab Activities, Equipment Briefings

• Perform microbiological sample analyses and quality control.
• Troubleshoot issues by ensuring non-compliances are investigated, actioned, and resolved.
• Report results for customers on time.
• Establish, review, and evaluate laboratory procedures and policies.
• Ensure equipment and facilities are maintained in accordance with approved procedures.
• Conduct technical projects.
• Plan and carry out trials.
• Investigate the growth, structural development, and characteristics of microscopic organisms.
• Isolate and culture different materials.
• Generate, analyze, and interpret microbiological data and reports.

Skills: Micro Sample Analysis, Issue Troubleshooting, Timely Reporting, Procedure Management, Equipment Maintenance, Technical Projects, Microbial Research, Data Interpretation

• Serve as an expert in molecular biology, microbiology, genomics, and metagenomics.
• Provide scientific insight to peers and collaborators.
• Design, plan, and research developing, improving, and applying molecular methods for detecting, identifying, and isolating bacterial pathogens in regulated commodities and the environment.
• Coordinate the activities of diverse laboratory research projects.
• Conduct research specializing in microbial genomics and metagenomics.
• Collaborate with colleagues inside and outside the agency.
• Serve as an expert in new technologies in modern microbiological and genomic sciences, such as whole genome sequencing, shotgun metagenomics, amplicon metagenomics, and emerging technologies.

Skills: Molecular Biology Expertise, Scientific Insight, Method Development, Project Coordination, Genomics Research, Collaboration, Technology Expertise, Pathogen Detection

• Assist with outbreak response activities.
• Perform tasks including specimen and test preparation, instrument use and maintenance, data interpretation, and results reporting for the Infectious Disease Lab.
• Perform testing for viral pathogens using molecular diagnostic tests.
• Isolate nucleic acids and perform PCR or molecular-based assays on pure cultures, clinical samples, and surveillance samples.
• Analyze assay data for the interpretation, recording, and reporting of results.
• Perform testing for viral pathogens using conventional or immunologic diagnostic techniques.
• Manage laboratory supply inventory and ordering.
• Assure the integrity of test results by performing established quality control testing and maintenance on equipment, media, and reagents.

Skills: Outbreak Support, Molecular Testing, Viral Diagnostics, PCR Assays, Data Interpretation, Immunologic Testing, Inventory Management, QC Maintenance

• Perform and interpret various laboratory tests common to clinical microbiology and clinical virology laboratories, including gold standard culture techniques and automated phenotypic and molecular identification of bacteria, yeasts, and viruses.
• Perform molecular biology techniques such as nucleic acid extraction, real-time PCR, and DNA sequencing, including next-generation sequencing.
• Contribute technical knowledge to assist with the development of test plans, experimental designs, and analytical methods.
• Draft reports for small projects or projects requiring routine analysis and testing.
• Maintain a clean and neat work area.
• Provide support to other laboratory areas, including preparing special chemicals or standardized solutions.
• Attend refresher courses in microbiology.

Skills: Clinical Testing, Molecular Techniques, Method Development, Report Drafting, Lab Maintenance, Cross-Lab Support, Solution Prep, Ongoing Training

• Test raw, in-process, and finished product.
• Test environmental conditions to monitor regulated areas.
• Test the water systems to ensure water quality is maintained.
• Calibrate and maintain instrumentation and methods.
• Test material to investigate customer difficulties.
• Maintain and record data clearly and precisely.
• Modify standard operating procedures.
• Perform identification and related testing in conjunction with microbial contamination.

Skills: Product Testing, Environmental Monitoring, Water Quality Testing, Instrument Calibration, Customer Investigation, Data Recording, SOP Updates, Microbial ID

• Lead the development and implementation of all contamination control measures and associated security processes, policies, and procedures for the Livingston site as the Company Microbiologist, reporting to the Head of Contamination Control.
• Serve as an active member of the cross-functional Quality Review Board, providing support and guidance in the absence of the Head of FCC while striving for aseptic excellence.
• Support the Head of Contamination Control in providing leadership in directing and supporting biological safety issues and investigations.
• Ensure that contamination control aspects of cGMP are strictly enforced and maintain a culture in which personnel understand the microbiology and hygiene requirements appropriate to their roles.
• Maintain updated files of all current regulatory requirements and guidelines relating to facility contamination control, including MHRA, EMA, and FDA expectations affecting aseptic processing, environmental monitoring, and sterility assurance for sterile pharmaceutical manufacturing facilities.
• Attend key meetings, including the Facility Contamination Control Committee, Quality Review Board, Investigations Review Board, Change Control Board, and daily QMS meetings, and provide guidance from a contamination risk perspective.
• Assist in writing and maintaining policies and standard operating procedures locally and globally to describe Valneva’s approach to Facility Contamination Control.
• Assist in training appropriate staff members on policies and procedures.

Skills: Contamination Control, Quality Leadership, Safety Support, cGMP Enforcement, Regulatory Monitoring, Risk Guidance, SOP Management, Staff Training

• Coordinate the activities of the Microbiology Laboratory in support of a 24/7 shift manufacturing operation and be indirectly responsible for the daily activities of the microbiology lab.
• Supervise the monitoring of the inventory of items in the microbiology lab.
• Perform procedures, validation, and training according to Good Manufacturing Practices and Corporate Quality Assurance.
• Perform laboratory-owned calibrations.
• Understand the principles of scheduling and how it relates to supporting the Sterility Assurance Program.
• Schedule and perform non-routine testing.
• Perform out-of-specification investigations.
• Back up approving the sterilization dose data when the Senior Microbiologist is absent.
• Coordinate and direct the incubator temperature profiles and the annual laboratory autoclave requalification.
• Assist with the development and documentation associated with new procedures, including the development of preventive maintenance programs.
• Responsible for purchasing supplies and maintaining the monthly budget, assisting in the preparation of the annual budget.
• Oversee the training of new associates or the implementation of new processes in the lab and initiate all technicians to perform their jobs while providing additional training and instruction to maintain satisfactory performance.
• Operate all equipment and perform all testing in the lab with basic troubleshooting skills.
• Uphold a high degree of accuracy and good technique in all laboratory procedures, including all testing associated with supporting a Sterility Assurance Program, such as media preparation, mathematical calculations, and maintaining records and log books, and be responsible for reviewing and approving reports, documents, and testing generated by the Microbiology Lab as specified by operating procedures.

Skills: Lab Coordination, Inventory Oversight, GMP Compliance, Calibration Tasks, Scheduling Support, Non-Routine Testing, OOS Investigation, Training Oversight

• Use scientific instruments and equipment, including autoclaves, water baths, pipette aids, and flow hoods.
• Make decisions or solve problems using logic to identify key facts, explore alternatives, and propose quality solutions.
• Apply knowledge of dilutions, pipette techniques, laboratory techniques, and safety practices.
• Apply knowledge of principles, theories, and practices of microbiology.
• Use scientific methods to solve problems.
• Review and edit documents for accuracy and completeness.
• Identify and apply appropriate safety intervention techniques.
• Compose and produce reports, documents, and related materials.
• Communicate information and ideas clearly and concisely in writing and read and understand information presented in writing.
• Apply microbiological testing and examination methodologies.
• Apply agency and organizational programs.
• Apply principles, theories, and practices of chemistry, including composition, structure, and properties of substances and the chemical processes and transformations they undergo, including uses, interactions, and danger signs.
• Ensure compliance with FDA 2400 PMO, ISO 17025 contract terms, policies, and procedures.
• Read, interpret, and apply FDA and State laws, rules, regulations, policies, and procedures.

Skills: Scientific Instrument Use, Problem Solving, Lab Techniques, Microbiology Knowledge, Documentation Review, Safety Practices, Report Writing, Regulatory Compliance

• Drive results in a fast-paced environment by assisting the manager in leading and coordinating the activities of a pharmaceutical microbiology group in compliance with cGMP and internal SOPs to support manufacturing and laboratory operations.
• Lead the team within the microbiology group to provide timely, compliant, and accurate testing of raw materials, in-process samples, and finished products, as well as monitoring of the environment and critical systems.
• Assist in the onboarding of state-of-the-art technologies and instrumentation, including IQ, OQ, PQ, and routine operation.
• Act as Subject Matter Expert in the application of isolator technology.
• Ensure all equipment is properly calibrated and serviced to support high throughput and full compliance.
• Assist in designing, monitoring, and testing programs and strategically evaluate processes for improvements and optimization.
• Support activities related to the commissioning of laboratory spaces.
• Write and review test procedures, verification, and validation protocols and reports.
• Review laboratory data, including environmental monitoring, microbiology testing, and equipment calibration data.
• Participate actively in cGMP inspections, client visits, and regulatory audits.
• Perform investigations and trending of all microbiological test data, including formal communication regarding the current control of GMP areas.
• Develop plans and lead corrective actions in response to excursions in controlled environmental areas.
• Lead development of testing templates in Electronic Laboratory Notebooks.
• Develop team members through adequate training, mentoring, and motivation, and ensure adherence to quality performance standards.

Skills: Team Leadership, cGMP Compliance, Tech Onboarding, Isolator Expertise, Equipment Oversight, Process Improvement, Audit Support, Data Review

• Perform microbiological testing, such as endotoxin and bioburden, for water.
• Perform microbiological testing, including endotoxin, sterility, and bioburden for raw materials, in-process materials, intermediates, and final product.
• Perform environmental monitoring of clean rooms under ISO and EU specifications.
• Read, trend, and report environmental, personnel, in-process, raw material, finished product, and water bioburden testing results.
• Perform microbial characterization, including Gram stain, catalase, oxidase, and coagulase tests.
• Prepare and send out samples for microbiological identification.
• Maintain historical files on organisms found in classified areas, including microbial identification and trending.
• Perform line clear and line start verifications.
• Inspect media fills.
• Perform additional microbiological assays.

Skills: Water Testing, Product Testing, Cleanroom Monitoring, Result Trending, Microbial Characterization, Sample Submission, Organism Tracking, Line Verification

• Perform sterility testing, including Biological Indicator testing.
• Perform growth promotion testing of all incoming media used in the microbiology laboratory.
• Perform Preservative Effectiveness testing.
• Perform Microbial Limits testing.
• Perform QC microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure.
• Initiate OOS, OT, or Environmental Monitoring Excursion investigations.
• Provide support for general QC Microbiology Laboratory activities.
• Perform chart reading and changing.
• Perform equipment cleaning and maintenance.
• Maintain supplies and inventory.
• Perform general laboratory housekeeping.

Skills: Sterility Testing, Growth Promotion, Preservative Testing, Microbial Limits, Sample Processing, OOS Investigation, QC Support, Lab Maintenance

• Provide high-level quality and regulatory leadership for complex environmental and microbiological control systems by developing, implementing, and enhancing standards and processes.
• Guide critical quality systems by determining necessary changes to standards and auditing users for compliance.
• Train system users on requirements and support targeted implementation to achieve business objectives.
• Provide microbiological testing and laboratory control support to project teams and manufacturing quality teams.
• Review microbiological standard test methods to ensure accuracy and consistency.
• Lead assessments of manufacturing operations against environmental and microbiological standards.
• Plan and oversee remediation activities when gaps or risks are identified.
• Provide cleaning and sanitization validation support by writing the needed protocols.
• Review, execute, and approve validation and change control protocols for assigned teams.
• Initiate corrective and preventive actions and ensure timely follow-up.
• Identify improvement needs within assigned systems and develop action plans to address them.

Skills: Quality Leadership, Standards Compliance, User Training, Micro Testing Support, Method Review, Operational Assessment, Remediation Planning, Validation Support

• Execute continuous improvement initiatives to strengthen system performance and reliability.
• Lead or support the creation and deployment of strategic quality management plans and measures.
• Work with quality and functional leaders to build environmental and microbiological capability across all organizational levels.
• Lead or support assessments of facilities, functions, and suppliers to provide expertise and mitigate risks.
• Ensure compliance with applicable quality management systems, medical device standards, and good cosmetic manufacturing practices.
• Provide subject-matter expertise to operations and design teams on quality, risk, and validation activities.
• Support risk management, change control, non-conformances, and acceptance sampling efforts.
• Administer the laboratory information management system for all supported sites.
• Provide backup leadership or support for designated product platforms.
• Demonstrate safety as a core value by performing all responsibilities safely and following all policies.
• Ensure quality assurance standards, regulatory requirements, and process control procedures are consistently met while maintaining strong communication and integrity.

Skills: Process Improvement, Quality Planning, Capability Building, Facility Assessment, Standards Compliance, SME Support, Risk Management, LIMS Administration

• Perform testing services within a microbiology laboratory, including human, animal, and plant diagnostics, surveillance, screening, environmental monitoring, and forensic science, to report clear and concise testing results.
• Perform, interpret, and report microbiological tests and assays for diagnosis, prevention, and treatment of illnesses or to determine sources of environmental contamination.
• Prepare specimens for scientific examination and analysis, and prepare the laboratory for accreditation audits and inspections.
• Conduct biological research experiments while applying quality control and quality assurance practices and adhering to regulatory standards.
• Operate and maintain laboratory instrumentation and information management systems.
• Prepare, review, verify, and report test result data.
• Communicate with internal and external stakeholders.
• Support and train new employees, students, and other professional colleagues.
• Utilize automated technology, isolate nucleic acids, perform real-time PCR assays, conduct conventional PCR, prepare samples for sequencing, and apply QC measures to limit contamination.
• Maintain proficiency in molecular diagnostics according to quality program guidelines.

Skills: Micro Testing Services, Test Interpretation, Specimen Prep, QC/QA Practices, Instrument Operation, Data Reporting, Stakeholder Communication, Molecular Diagnostics

• Participate in the NAHLN testing program, maintain proficiency by passing annual testing requirements, complete molecular testing on a rotational basis, and respond to foreign animal outbreaks.
• Receive diagnostic specimens for molecular testing and maintain records.
• Process molecular samples by homogenizing or soaking samples, pooling samples, and processing semen samples.
• Consult with case coordinators or pathologists regarding testing requests.
• Perform other assigned duties, such as maintaining a clean workspace, ensuring work duties are covered, providing technical advice and training, preparing samples for referrals, and serving on committees.
• Participate in section-specific programs, including oligo preparation, assay control, media and mastermix preparation, and reagent qualification programs.
• Perform section-wide duties such as preparing media, maintaining QC records, operating autoclaves, maintaining media clean room status, and ensuring adequate reagent and consumable supply.
• Comply with WVDL safety and quality requirements.
• Assist investigations into new equipment and technologies, make recommendations on assay improvements, and troubleshoot procedures, including next-generation sequencing.

Skills: NAHLN Testing, Specimen Management, Sample Processing, Case Consultation, Workspace Maintenance, Section Programs, QC Operations, Assay Improvement

• Report to Quality Control Management as the Quality Control Microbiologist I.
• Perform release testing on finished products following Standard Operating Procedures and in-house test methods.
• Submit samples to contract labs with appropriate documentation, and follow Current Good Manufacturing Practice documentation guidelines to record all procedures in a timely fashion while reporting results of analyses on finished product Certificates of Analysis.
• Document all routine and non-routine microbiological testing performed on raw materials, finished products, and special request samples, whether performed in-house or by the certified contract laboratory.
• Initiate investigation reports for out-of-specification laboratory data.
• Perform evaluation and validation testing on finished products and raw materials following Standard Operating Procedures, in-house test methods, and industry guidelines.
• Execute Evaluation Protocols as well as Evaluation and Validation Reports and Summaries following Current Good Manufacturing Practice documentation guidelines for presentation to Quality Control and Upper Management.
• Collect Environmental Monitoring samples following Quality Control Microbiology SOPs, operate the APC Airborne Particle Counter, and the SAS Air Sampler.
• Handle media plates for Environmental Monitoring sampling while scrutinizing, documenting, and interpreting Environmental Monitoring results.
• Communicate Environmental Monitoring trends and findings to Quality Control, Manufacturing, or Packaging Management.

Skills: Release Testing, Sample Submission, cGMP Documentation, OOS Investigation, Validation Testing, EM Sampling, Data Interpretation, Trend Reporting

• Provide input for improving existing Standard Operating Procedures, test methods, and other protocols and policies throughout the Micro Laboratory.
• Participate in implementing new procedures and authoring new Standard Operating Procedures.
• Review and sign off on reports and Certificates of Analysis generated by other Quality Control personnel.
• Understand all equipment and methods used throughout the Quality Control Microbiology Laboratory, including Laboratory Balances, Biolumix Rapid Microbiology Systems, Autoclave, Incubators, Stomacher, Microscope, and the Bio-Safety Hood, and troubleshoot personal analyses or experiments using sound scientific judgment.
• Assist other analysts in the laboratory with troubleshooting instrumentation or microbiological analyses.
• Assist in developing and executing test methods for microbiological media testing for suitability and in interpreting organism growth from samples and controls.
• Assist in gathering information and data for product or situation investigations relevant to the Quality Control Microbiology Laboratory or to Quality Control as a whole.
• Assist in training new laboratory personnel and document all training performed under supervision in accordance with established Standard Operating Procedures and the Laboratories, Inc. training program.
• Maintain a safe working environment and ensure that all equipment used in testing procedures is calibrated and properly maintained.
• Assist with the QC Chemistry Laboratory with any chemistry application of which (s)he is knowledgeable and trained.

Skills: SOP Improvement, Document Review, Equipment Mastery, Troubleshooting Support, Method Development, Data Gathering, Staff Training, Safety Compliance

• Provide leadership for the food safety design and corporate HACCP pillar of the internal quality program, and deliver food safety support to the internal manufacturing locations.
• Work with the food safety and quality team as the central point for microbiological consultation and provide subject matter expertise on microbiological improvements.
• Provide leadership as the owner of the corporate food safety design program.
• Provide guidance and input into the corporate HACCP design.
• Lead the development of case studies and position papers for food safety criteria and support model control programs linked to CCP and oPRP applications.
• Own the development and updates of microbiological standards.
• Provide subject matter expertise for the development of microbiological standards for finished products, intermediate materials, raw materials, and customer requirements.
• Support internal laboratory teams in standards development and method validations.
• Serve as the central liaison between the organization and external testing partners to approve testing laboratories, advise on advanced methodologies, and validate methods and approvals for routine testing.
• Provide central leadership and technical support for the environmental pathogen monitoring program and hygienic zoning program.
• Contribute input to quality policies through regular updates.
• Conduct food safety training and review, track, and trend results.
• Support investigations, annual site assessments, and program reviews.
• Support food safety risk assessment outcomes for products.
• Support food safety incidents and recommend improvements based on lessons learned.

Skills: Food Safety Leadership, Microbiology Expertise, HACCP Guidance, Standards Development, Method Validation, Lab Liaison, Pathogen Monitoring, Risk Assessment

• Provide support for ingredient hazard assessments and approval of validation and verification documentation.
• Collaborate strongly with supply quality, manufacturing, regulatory, and procurement teams.
• Provide central support for integrated change management related to new product development and research trials requiring microbiological risk assessment.
• Partner with research and supply chain teams to complete hazard assessments, identify and validate preventive controls, and communicate information to manufacturing sites.
• Perform internal HACCP validations on a scheduled frequency.
• Support manufacturing sites in updating and maintaining food safety plans and rolling out supporting references and tools.
• Provide central support to manufacturing sites for thermal process validations.
• Design and coordinate the completion of thermal profiling and surrogate studies for ready-to-eat and ready-to-heat production lines.
• Contribute to team meetings at quality community sessions.
• Provide advice and support to team members.
• Work closely with relationship holders, senior managers, and knowledge managers.
• Identify personal development needs and agree on priorities.
• Take proactive actions to address personal development needs.
• Keep up to date with product and service developments.

Skills: Hazard Assessment, Cross-Functional Support, Change Management, Preventive Controls, HACCP Validation, Food Safety Planning, Thermal Validation, Team Collaboration

• Perform a variety of microbiological analyses on products, raw materials, water, and in-process materials per quality system requirements.
• Interpret, evaluate, and report analyses in terms of accuracy and precision.
• Monitor and verify quality in accordance with statistical process control and conduct certification and training of employees based on test methods and procedures.
• Apply method, instrument, and data systems expertise to resolve problems.
• Link analytical and microbiological results with a basic understanding of manufacturing and packaging.
• Provide timely, highly accurate, and precise chemical and microbiological analysis on raw materials, in-process materials, and packages.
• Perform analysis ranging from basic wet chemistry, sampling, and plating to advanced testing.
• Participate in proficiency testing to ensure accuracy and precision of techniques, methodology, or equipment.
• Perform, interpret, and evaluate analytical chemistry and microbiological analyses.
• Conduct basic and advanced trending and provide immediate reporting of data to teams to stabilize and improve the process.
• Utilize statistical analysis tools such as SPC and control charts for summarizing and reporting data and trends, and for monitoring laboratory equipment.
• Develop, improve, and implement quality data collection, analysis, and reporting processes to provide the best information to the decision-making point in the process.
• Coordinate effective and timely communication of trends and reporting, and enable teams to take appropriate actions for continuous process improvement.

Skills: Micro Analysis, Result Evaluation, SPC Monitoring, Method Troubleshooting, Manufacturing Insight, Advanced Testing, Data Trending, Process Improvement

• Monitor, calibrate, and maintain instruments inside and outside the laboratory.
• Perform troubleshooting of instruments and methods.
• Perform advanced repairs and preventive maintenance, including coordination with equipment vendors.
• Perform routine water sampling and maintenance for the manufacturing water system.
• Facilitate and participate in problem-solving and quality-improvement teams.
• Participate as subject matter experts to support problem-solving and quality-improvement initiatives.
• Participate in best practices such as 5S within the quality labs and production.
• Educate, train, and influence teams, leaders, and support groups to achieve continuous improvement by reducing process variation and controlling processes to specification targets.
• Follow all performance, talent, and career management processes.
• Manage an individual development plan.
• Participate in a team-based environment and structured communications.
• Work in collaboration with chemical lab technicians and support manufacturing.
• Encourage and influence teams and employees to recommend, implement, and transfer knowledge on new ideas, shared learnings, and best practices to optimize performance.
• Build effective partnerships across the GMP manufacturing network.

Skills: Instrument Maintenance, Troubleshooting, Advanced Repairs, Water System Support, Problem Solving, 5S Practices, Training & Coaching, Cross-Functional Collaboration

• Model behaviors that support a continuously improving EHS culture and engage with employees and other key stakeholders.
• Ensure all EHS requirements are met while coaching and directing individuals to deliver EHS performance for themselves, their team, and their department.
• Prepare for and actively participate in internal and external EHS audits and incident or accident investigation and reporting, and implement Corrective and Preventive Actions on time.
• Model behaviors that ensure delivery of high-quality products for customers while maintaining compliance with company, division, and plant policies and procedures, and meeting all local, statutory, and international regulatory requirements.
• Prepare for and actively participate in internal and external Quality audits and incident investigation, reporting, and implement Corrective and Preventive Actions on time.
• Lead the operation of the plant microbiology QA laboratories, including the Environmental Monitoring Program, biochemical characterization and identification, raw material and finished product testing, appropriate adherence to methods and procedures, and completion of CAPA activities.
• Provide direction and technical expertise to microbiology laboratory personnel and to the plant.
• Provide leadership during problem-solving situations related to microbial issues.
• Model a thorough understanding of what drives product costs, profitability, and cash flow for the shift and department while managing budgets for headcount, overtime, and direct expenses, and continuously improving budgetary performance.
• Understand financial statements and key performance measures, and provide input for all line budget decisions while developing skills to manage budgetary items and participating in annual budget preparation.
• Demonstrate financial accountability up to a generalized monetary amount.
• Promote and drive continuous improvement projects and utilize common problem-solving tools and methodologies for root-cause analysis and issue resolution.

Skills: EHS Leadership, Audit Participation, CAPA Execution, Quality Compliance, Lab Oversight, Technical Guidance, Problem Solving, Budget Management

• Plan and organize day-to-day laboratory operations and schedules proactively.
• Anticipate and drive proper alignment and prioritization between the laboratory and production teams.
• Model the organization’s values while providing effective leadership, direction, development, and support to the team.
• Ensure team members are trained and understand duties, responsibilities, and performance expectations.
• Provide timely coaching, counseling, and feedback.
• Develop all line personnel by securing training, providing mentoring, and assigning progressively challenging responsibilities.
• Draft personal goals and lead the development of team goals and growth planning while creating a learning environment that supports individual development plans.
• Ensure delivery of effective performance management while maintaining a positive work environment.
• Execute on-time performance reviews for direct reports.
• Establish a communications framework that ensures the timely and relevant transfer of information across all levels and functional areas.
• Ensure compliance with all HR practices, policies, and procedures.
• Use rewards and recognition programs effectively.
• Champion positive employee relations by maintaining a strong presence on the floor, engaging directly with employees, and encouraging open communication and knowledge sharing.
• Ensure laboratory test results reflect compliance with plant, division, and corporate guidelines and procedures.
• Attend plant quarterly quality review meetings to communicate and oversee microbiological issues.
• Track capital requests for laboratory equipment and facilities.

Skills: Lab Operations Planning, Team Leadership, Training & Development, Performance Management, Communication Framework, HR Compliance, Employee Relations, Quality Oversight

• Experience in Microbiology or a related science discipline.
• Knowledge of cGMPs and related compliance regulations and guidances.
• Must have the ability and skill to perform the detailed job requirements noted above competently, safely, and proficiently.
• A self-starter, motivated person who possesses good interpersonal skills and is capable of effectively interacting with all departments and client personnel.
• Excellent organizational, verbal communication, and technical documentation skills.
• Solid computer skills.
• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
• Must be a team player with integrity and concern for the quality of the Company's products, services, and staff members.

Qualifications: BS in Cell Biology with 2 years of Experience

• Experience with standard cell culture, molecular, and microbiological techniques.
• Experience in documentation of daily work with good laboratory and QMS practice compliance.
• Extensive experience writing or preparing project proposals, reports, research protocols, and standard operating procedures.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Relevant Labware LIMS experience.
• Strong organization skills, including the ability to follow assignments through to completion.
• Ability to work independently, as well as be a member of a team in a dynamic, fast-paced environment.
• Excellent communication and interpersonal skills.
• Proven high level of attention to detail.

Qualifications: BA in Microbiology with 3 years of Experience

• Experience working in a microbiology laboratory environment.
• Experience in an FDA-regulated business or ISO:13485 Quality System.
• Good computer skills and proficiency with Microsoft Word, Excel, and PowerPoint.
• Must be able to learn and work with computer software such as SAP and LIMS, and any other applicable laboratory software.
• Excellent organizational, problem-solving, prioritizing, and follow-up skills.
• Strong technical writing skills, including reports and laboratory logbooks.
• Effective verbal and written communication, interpersonal, and team-building skills.
• Must be able to read, write, and understand English.
• Must be able to work with minimum supervision.
• Ability to handle multiple tasks/projects simultaneously.
• Strong statistics and sampling plans background with DOE experience.
• Ability to train colleagues in Micro-related procedures and methods.

Qualifications: BA in Biochemistry with 4 years of Experience

• Experience in the relevant testing discipline within the Pharmaceutical industry.
• Experience in Quality Control testing techniques.
• Experience in a cGMP environment or Industry practices.
• Awareness of test and equipment validation.
• Working knowledge of continuous improvement and root cause analysis techniques.
• Fluent in English, both verbal and written.
• Close attention to detail.
• Good team-building/relationship-building abilities.

Qualifications: BS in Biotechnology with 1 year of Experience

• Experience in Microbiology, preferably in pharmaceutical manufacturing
• Previous training and experience in environmental monitoring, sampling, and laboratory microbiology (USP 71, Growth Promotion Testing, Methods Validation).
• In-depth knowledge of environmental monitoring, sampling, microbial testing, and microbial method validation requirements.
• Experience with Rapid Microbiological testing methods.
• Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing.
• Bring a positive, professional attitude.
• Strong organizational skills.
• Ability to work independently and in a team environment.
• Thrive in a fast-paced environment and adapt to changing priorities.
• Detail-oriented individual who understands the importance of accuracy and responsiveness.
• Ability to collaborate with team members and cross-functionally.

Qualifications: BA in Biology with 5 years of Experience

• Practical microbiology laboratory experience.
• Knowledge of general laboratory equipment (such as incubators, autoclaves, microscopes, and water baths).
• Practical knowledge of the laboratory working environment through job experience or college classwork.
• Ability to conduct failure investigations.
• Must understand basic lab safety and chemical waste disposal.
• Practical experience with good laboratory practices (GLPs).
• Display a high energy level and put top priority on getting results.
• Ability to make decisions and communicate effectively while under pressure.
• Ability to develop relationships with people throughout the facility.
• Excellent interpersonal, communication skills, and ability to work in a team environment.
• Strong multitasking skills in a fast-paced, changing environment.

Qualifications: BS in Genetics with 2 years of Experience

• Laboratory experience in a supervisory position, preferably in microbiology laboratories, in Quality Control for a pharmaceutical or biopharmaceutical company.
• Experience in developing laboratory SOPs and revisions according to regulatory guidelines.
• Effective oral and written communication skills.
• Ability to appropriately communicate information to cross-functional stakeholders and suppliers.
• Strong knowledge of GMP, ISO, and safety guidelines.
• Solid knowledge of all laboratory equipment (e.g., Vitek, Celsis, Autoclave).
• Strong problem-solving skills.
• Knowledge of statistical assessments of data.
• Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems.
• Good English, German as communication in the lab is in German.

Qualifications: BS in Molecular Biology with 6 years of Experience

• Experience with basic lab equipment, such as pH, balances, viscometers, etc., and microbiology methods
• Experience with general documentation practices and cGMP compliance with notebooks, data entry forms, with specific attention to details
• Experience with common microbiology lab instrumentation (i.e., autoclaves, air amplers, light microscope, biohazard cabinets, and water purification system).
• Familiar with quality systems such as failure investigations, Corrective and Preventive Actions, calibration, change control, etc.
• Good computer skills (i.e., MS Word, MS Excel, e-mail).
• Must understand basic lab safety, bio-hazard, and chemical waste disposal practices
• Ability and flexibility to work a rotational schedule to support a 24/7 plant facility operation
• Strong relationship-building skills
• Effective communication to speaking and writing effectively, and keeping people up to date with information.
• Ability to maintain lab notebooks and testing documentation.

Qualifications: BS in Environmental Science with 3 years of Experience

• Experience as a microbiologist in a manufacturing lab work environment.
• Experience in an FDA-regulated environment.
• Knowledge and experience with GLP in a microbiology lab environment.
• Competent with microbiology techniques, such as Gram staining, isolation plating, media preparation, and microorganism identification methods.
• Practical experience in an industrial environment at a manufacturing site implementing cGMPs.
• A high energy level and able to prioritize duties to get effective results.
• Ability to make decisions and communicate effectively while under pressure
• Experience working with SAP.
• Working knowledge of good documentation practices, lab note recordkeeping, and concise report publishing.

Qualifications: BS in Marine Biology with 4 years of Experience

• Related laboratory work experience in a pharmaceutical environment, or an equivalent combination of training and experience.
• Be able to read, write, and speak English.
• Ability to read and comprehend Company policies and procedures, including safety rules and regulations.
• Ability to multitask and have good time management skills.
• Must have good communication and customer service skills.
• Ability to generate innovative ideas and solutions to problems and stimulate others to continuous improvement.
• Strong teamwork skills.

Qualifications: BS in Immunology with 1 year of Experience

• Laboratory experience in a pharmaceutical or related industry.
• Quality Control background.
• Demonstrated practical problem-solving skills and the ability to carry out responsibilities under general supervision.
• Able to manage time and organize workload for effective implementation.
• Strong customer and results orientation.
• Ability to interact effectively at all levels with sensitivity to cultural diversity.
• Ability to function as an effective team member.
• Adaptive and evolves with the changing external environment and organization.

Qualifications: BA in Human Biology with 2 years of Experience

• Hands-on experience running and analyzing optical density assays to assess microbial growth patterns.
• Strong capability in designing combinatorial, plate-based experimental protocols for complex research needs.
• Experience cultivating diverse microbial isolates with varying growth rates and media requirements.
• Proficiency in preparing complex custom media and adapting formulations to suit organism-specific needs.
• Able to operate standard laboratory equipment, including balances, centrifuges, pipettes, and mixers.
• Strong motivation, organization, discipline, and exceptional record-keeping with superb attention to detail.
• Solid chemistry knowledge, such as solution preparation, molarity calculations, and reagent handling.
• Experience in performing quality assurance activities and implementing appropriate experimental controls.
• Experience using documentation systems such as lab notebooks and spreadsheets to accurately track procedures and data.
• Proven ability to troubleshoot laboratory equipment and instrumentation to ensure consistent performance.
• Excel in R and/or Python for data analysis and works comfortably with robotics platforms.
• Experience performing growth assays across a wide range of organisms.

Qualifications: BS in Biomedical Science with 5 years of Experience

• Experience in a GMP-regulated industry.
• Experience in a laboratory environment.
• Experience with sterile aseptic techniques for laboratory and clean room practices.
• Microbiology testing knowledge (membrane filtration and plate count methods).
• Prior experience using Microsoft Word and Excel.
• GMP and/or GLP training.
• Can read and interpret safety rules, operating manuals, maintenance instructions, and laboratory procedures.
• Can remain current with regulatory requirements and emerging industry trends.
• Strong organizational skills.

Qualifications: BA in Biological Sciences with 3 years of Experience

• Experience in food-related microbiology.
• A proven record of initiative, innovation, and research efficiency.
• Experience in technology development and implementation.
• Self-starter with the ability to thrive in a diverse and fast-paced environment.
• Excellent interpersonal and teamwork skills.
• Inclination to challenge assumptions to seek innovative solutions.
• Track record of working cross-functionally.
• Mentorship and managerial experience.

Qualifications: BS in Clinical Laboratory Science with 6 years of Experience

• 3rd Level Qualification in Microbiology or relevant Science qualification with emphasis on Biological Sciences.
• Experience in a Microbiology Laboratory environment.
• Ability to work in a fast-paced and high-volume Microbiology role.
• Experience working in a highly regulated industry.
• Superb attention to detail.
• Ability for critical thinking and problem-solving.
• Ability to communicate and work with all manner of team members conscientiously and inclusively.

Qualifications: BS in Agricultural Science with 2 years of Experience

• Experience in a research laboratory environment, protein and nucleic acid extraction, real-time PCR, immunological analysis, and high-throughput sequencing (Illumina and ONT MinION).
• Experience with bioinformatics tools and pipelines for metagenomic data analysis.
• Familiarity with Linux systems, including high-performance computing (HPC) environments.
• Experience with science or technical writing.
• Experience in a BSL-2 laboratory.
• Good PC skills and the ability to learn new software and systems.
• Ability to effectively communicate and interact with technical staff at all levels in a team-based environment.
• Ability to develop and improve methods, test plans, and experimental designs as directed by the principal investigator.
• Excellent interpersonal and communication skills.
• Ability to multitask and be flexible to adjust priorities.

Qualifications: BA in Public Health (Biology Focus) with 4 years of Experience

• Experience working within Microbiology in a GMP facility, ideally in the pharmaceutical/biotechnology industry.
• Understanding of KPI’s for the site.
• Knowledge of quality management systems.
• Experience in performing Sterility testing, requalifications.
• Knowledge of the use and maintenance requirements of a Sterility testing isolator.
• Excellent communication skills and being a natural influencer.
• Ability to work effectively in cross-functional teams.
• Excellent computer aptitude with proficiency in word processing and spreadsheet software.
• Strong integrity, independent work habits, multitasking abilities, and hygiene awareness.

Qualifications: BS in Bioinformatics with 5 years of Experience

• Laboratory experience or equivalent combination.
• Good ability to distinguish colors for Microbiological testing.
• Proven troubleshooting skills.
• Ability to work as part of a team.
• Positive outlook with the ability to adapt to changing circumstances.
• Strong verbal and written communication skills.
• Punctual and reliable in attendance.
• Great attention to detail.

Qualifications: BS in Toxicology with 1 year of Experience

• Professional experience working as a Microbiologist.
• Working knowledge of Microbiological assays.
• Experience with MS Excel and Word.
• Good proofreading skills.
• Ability to work in a team environment and independently.
• Ability to follow laboratory testing procedures.
• Good communication skills, both verbal and written.
• Ability to make sound, compliant decisions.

Qualifications: BA in Chemistry (Biological Focus) with 2 years of Experience

• Experience in the Pharmaceutical/Medical Devices Industry Lab.
• Familiar with good documentation practices.
• Able to work with computer programs, such as SAP, MS Word, Excel, and Outlook.
• Experience in working with laboratory equipment and computer software.
• Knowledge of statistics.
• Ability to read and interpret documents such as safety rules, operating, and maintenance instructions, procedure manuals, and drawings.
• Proven technical writing skills.
• Be bilingual in English and Spanish.
• Ability to work and prioritize independently.

Qualifications: BS in Forensic Science (Biology Track) with 3 years of Experience

• Experience working in a regulated laboratory.
• Knowledge of various laboratory instrumentation, including biological safety cabinets, steam sterilizers, incubators, microscopes, water baths, vortexers, balances, pH meters, etc.
• Must adhere to Company and Department policies and procedures as well as government regulations.
• Understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, and Current Good Manufacturing Practices (cGMPs).
• Strong basic math skills, ability to communicate (written and verbal).
• Proven ability to use a respirator.
• Ability to read and interpret general business documents.
• Ability to write routine reports and general business correspondence.
• Ability to work with peers and communicate basic concepts.
• Good statistical analysis and advanced mathematical calculations.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
• Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
• Experience in office and BSL-2 laboratory environments.

Qualifications: BS in Pharmaceutical Sciences with 4 years of Experience

• Understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA).
• Experience in classical microbiology techniques (i.e., Gram staining, streak plating, culture maintenance, and aseptic techniques)
• Experience in microscopy, autoclave, and biological and laminar flow hood usage.
• Working knowledge of mathematics and statistics.
• Excel in microbial sample preparation techniques.
• Proficiency in reading, writing, and speaking English
• Able to read and comprehend Company policies and procedures, including safety rules and regulations.
• Ability to multitask with time management skills.
• Strong communication and customer service skills.

Qualifications: BS in Medical Laboratory Science with 2 years of Experience

• Relevant experience in a specialty or food manufacturing micro-laboratory.
• Understanding of product certification programs such as Kosher, Halal, and Organic.
• Awareness of FSSC 22000, HACCP, SPC, and AIB product safety systems.
• Understanding of GMP and GLP requirements.
• Knowledge of food and facility security requirements.
• Good at oral and written communication.
• Consumer/customer satisfaction focused.
• Understanding of "cost of quality".
• Comfortable working in a fast-changing and growing global environment where accountability, quality, and timeliness.
• Ability to perform work collaboratively.

Qualifications: BA in Health Sciences (Biology Emphasis) with 3 years of Experience

• Third-level qualification in Microbiology or related discipline.
• Experience within a pharmaceutical GMP environment.
• Previous working experience with direct inoculation, with knowledge and application of principles associated.
• Previous method transfer and validation experience.
• Previous people management experience.
• Excellent interpersonal and communication skills.
• Good leadership abilities.
• Strong decision-making skills and the ability to work on your own initiative.
• Ability to work with minimum supervision.
• Comfortable and willing to travel internationally.

Qualifications: BS in Pathobiology with 5 years of Experience

• Experience in dairy microbiology, food microbiology, or general Microbiology with experience in a relevant research setting.
• Strong background in dairy starter cultures.
• Strong knowledge and hands-on experience in dairy technology.
• Proven industry experience.
• Excellent verbal and written communication skills with close attention to detail.
• Strong interpersonal and critical thinking skills.
• Knowledge of statistical analysis.
• Proficient in Microsoft Office (Word, Excel, and PowerPoint).
• Excellent organization and time management skills.

Qualifications: BS in Neuroscience with 4 years of Experience

• Strong technical knowledge and experience of Microbiology methods and applications.
• Demonstrated interest in the application of Microbiology principles to industrial settings.
• Demonstrated ability in the performance of QC Microbiology methods (in industry or other settings, including college projects).
• Awareness of regulatory standards and how they apply to Pharmaceutical Microbiology.
• Experience working in a cross-functional team environment.
• Awareness of cGMP and GLP standards.
• Flexibility and ability to manage time and conflicting priorities.
• Positive and enthusiastic attitude.
• Ability to form strong relationships cross-functionally.
• Dynamic and motivated by projects and common goals.
• Inquiring and enjoys gaining knowledge and solving problems.

Qualifications: BA in Microbiology with 2 years of Experience

• Experience in Food Science, Microbiology, or a related field.
• Must be a Preventive Controls Qualified Individual.
• Demonstrable knowledge of HACCP/Food Safety Plans and related food safety systems as applied at the food manufacturing plant level.
• Outstanding interpersonal and communication skills (written and verbal).
• Strong technical leadership with an understanding of business needs and processes.
• Demonstrated external leadership with a record of accomplishment relative to food safety via trade associations, academic consortia, and in the regulatory arena.
• Experience with government regulations (FDA/USDA/CDC/State and Local, as well as international).
• Track record of successfully managing cross-functional teams and technical teams in the area of food safety.
• Excellent report writing skills.
• Working knowledge of statistical and analytical tools.
• Must be able to travel independently and as a responsible Company representative.

Qualifications: BS in Cell Biology with 6 years of Experience

• Experience in microbiological analysis development and validation.
• Experience in practical microbiological analysis.
• Experience from a GMP or accredited laboratory.
• Experience with regulatory documentation.
• Fluent in oral and written Norwegian.
• Ability to work in teams and independently.
• Have a focus on customer needs and set high standards for quality.
• Ability to manage time effectively in a high-pressure environment.
• Ability to listen, consult others, and communicate proactively.

Qualifications: BS in Molecular Biology with 3 years of Experience

• Microbiology lab or aseptic experience.
• Experience in microbiological techniques, including culturing, sub-culturing, inoculation, isolation, characterization, and identification of bacteria and fungi.
• NJ certified Pharmacy Technician (on job acceptance).
• Obtained knowledge of regulatory guidelines, specifically 21 CFR 210 & 211, USP 795, 797 & 800, ICH Q1AR2 and Q1D, and 503B Guidance.
• Experience with environmental sample collection.
• Experience with data trending and analysis.
• Experience with microscopy.
• Knowledge of/experience with sterility testing.
• Knowledge of/experience with endotoxin testing.
• Knowledge of/experience with aseptic compounding.
• Knowledge of process/pharma manufacturing.
• Knowledge of/experience with Equipment Qualification/Validation.

Qualifications: BS in Genetics with 4 years of Experience

• Professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.
• Familiar with the manufacturing process and how QA/QC fits in.
• Understanding of Microbiology laboratory procedures.
• Strong computer skills, including MS Office programs.
• Ability to operate laboratory equipment and interpret results.
• Good verbal and written communication skills.
• Flexible to coordinate the timing of projects.
• Able to work independently.
• GMP training and certification.

Qualifications: BA in Biochemistry with 2 years of Experience

• Previous experience working in a GLP environment.
• Excellent general microbiology laboratory skills and aseptic technique.
• Ability to perform microbiology testing protocols accurately and efficiently.
• Strong organizational and time management skills.
• Can document work carefully, maintain an electronic lab notebook, and other key documentation.
• Ability to work in a multidisciplinary team (including microbiology, chemistry).
• Ability to properly operate and maintain laboratory equipment.

Qualifications: BS in Biotechnology with 1 year of Experience

• Experience in a laboratory, working to GMP guidelines.
• Experience working in a sterile environment.
• Sterility testing experience.
• Endotoxin testing experience.
• Previous bioburden experience.
• Experience working with the LIMS system.
• Experience with environmental monitoring.
• Strong communication skills, both verbal and written.
• Ability to work alone and as part of a team.
• Strong work ethic.

Qualifications: BA in Biology with 3 years of Experience

• MLT Certification through the ASCP, or eligibility to become certified.
• Proven clinical lab experience.
• Supervisory experience.
• Good critical thinking skills to work with documents and spreadsheets and interpret information furnished in written, oral, diagram, or schedule form.
• Ability to manage a diverse workload and prioritize tasks.
• Exceptional customer service skills with a professional demeanor that ensures trust, competence, and compassion amongst team members.
• Ability to work well in a team environment, as well as the ability to work independently.
• Strong computer and organizational skills.
• Excellent oral and written communication skills.

Qualifications: BS in Environmental Science with 4 years of Experience

• Relevant medical device sterilization experience with a concentration in Radiation and Ethylene Oxide.
• Proven technical skills with multiple sterilization processes.
• Sterilization experience supporting class III medical devices.
• Extensive knowledge and understanding of Edwards’ policies and procedures relevant to microbiology, including contamination control and sterilization (Radiation and Ethylene Oxide).
• Thorough knowledge of the compliance guides for environmental controls or a sterilization process (proficiency in ISO 11135 and ISO 11137).
• Extensive knowledge and understanding of Microbiology principles, theories, and concepts.
• Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance (e.g., ISO, GLP/GMP/QSIT).
• Excellent facilitation and presentation skills.
• Excellent problem-solving, organizational, analytical, and critical thinking skills
• Must adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others, as well as to the protection of the environment and prevention of pollution under their span of influence/control.
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.

Qualifications: BS in Immunology with 8 years of Experience

• Strong experience with microbiology methods and procedures.
• Experience in developing new assays and troubleshooting.
• Must be a US citizen with the ability and willingness to obtain security clearance.
• Ability to obtain/maintain certification in Chemical Personnel Reliability Program (NACLC) and/or Biological Personnel Reliability Program (Single Scope Background Investigation required for entry.
• Ability to obtain/maintain DoJ Security Risk Assessment (SRA) approval.
• Ability to obtain/maintain CDC approval to work with BSAT material.
• Must be willing to work in a biosafety level 2 (BSL2) and/or 3 (BSL3) (biocontainment) environment and able to wear appropriate respiratory protection.
• Must be willing to be immunized with FDA-licensed vaccines and Investigational New Drugs (IND) recommended for persons at risk of occupational exposure to biological agents.

Qualifications: BS in Biomedical Science with 6 years of Experience

• Work experience in similar roles, preferably in the Pharmaceutical Industry.
• Proficiency in numeracy and IT skills.
• Strong oral and written communication skills.
• Superb problem-solving and analytical skills.
• Able to work well in a team and to manage own workload.
• Ability to perform computer tasks and operate common computer programs.
• Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Be able to interpret a wide variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Qualifications: BA in Human Biology with 1 year of Experience

• ASCP Certification.
• Experience working in a CLIA-certified clinical laboratory environment, ideally with specific microbiology experience.
• Demonstrated technical competency in clinical microbiology, including experience in culture and identification of clinical microorganisms, staining, and anti-susceptibility testing.
• Experience in molecular microbiology technologies.
• Good knowledge of instrumentation and equipment used in a laboratory, and in laboratory procedures and processes.
• Excellent communication skills and the ability to communicate effectively and professionally with the laboratory team and clients.
• Must be self-motivated and able to prioritize work.
• Efficiency in word processing applications, spreadsheet design/utilization, and use of web-based resources.
• Excellent customer service and interpersonal skills.
• Ability to work collaboratively with the laboratory team.

Qualifications: BA in Biological Sciences with 3 years of Experience

• Analytical Background with Microbiology knowledge.
• Technical and practical understanding of laboratory equipment, procedures, and methods
• Progressive experience in Quality Control, or equivalent combination of education and experience.
• Experience in aseptic processing, cell therapy, and FDA inspections.
• Strong knowledge of US and EU pharmaceutical GMPs.
• Must be familiar with the implementation of microbiological environmental monitoring programs.
• Understanding of the interpretation of microbiological data, including evaluation of trends.
• Ability to work on your own initiative.
• Be a strong team player.
• Proficiency in MS Office Applications - Word, Excel.

Qualifications: BS in Clinical Laboratory Science with 5 years of Experience

• Experience with Industrial Microbiology.
• Relevant quality and/or manufacturing experience.
• Strong knowledge and understanding of Good Manufacturing and Laboratory Practice.
• Experience with FDA/GMP guidelines.
• Strong leadership and communication skills.
• Must have experience with cell-based assays.
• Hands-on experience with virology.
• Excellent time management skills.
• Ability to take ownership of issues and work towards resolution.

Qualifications: BA in Public Health (Biology Focus) with 4 years of Experience

• Experience working in a GMP analytical lab.
• Experience with Endotoxin testing.
• Working knowledge of pharmaceutical cGMP and quality assurance requirements.
• Experience with pharmacopeia testing.
• Good troubleshooting and problem-solving skills.
• Good verbal communication, organization, presentation, and technical writing skills.
• Able to review complex documents like contracts and leases.
• Able to review quantitative and qualitative work and identify questionable items.
• Able to set goals based on available information and to plan work to meet deadlines.

Qualifications: BS in Bioinformatics with 2 years of Experience

• Relevant experience in the microbiology laboratory
• Good understanding of Safety, GLP, and well knowledge of microbiological lab accreditation work of SAC-SINGLAS (ISO 17025).
• Experience in operating laboratory equipment and the lab computer system.
• An analytical development mindset in research and commercialization activities.
• Expertise in sterilization standards and compliance documents.
• Expertise in endotoxin testing, limits, and standards compliance.
• Expertise in microbiology lab testing, including bioburden and sterility testing.
• Expertise in EO residual testing and requirements.
• Expertise in CEA compliance and certification.
• Good written and verbal communication skills.

Qualifications: BS in Toxicology with 4 years of Experience

• Experience with microbiological processes and aseptic technique.
• Experience working in a regulated environment (GLP or GMP).
• Ability to make basic mathematical computations.
• Ability to operate in a detail-oriented, self-directed manner.
• Able to express oral and written communication clearly and concisely.
• Ability to effectively present information and respond to questions from managers, customers, and employees.
• Able to lift boxes and general office supplies weighing up to 25 pounds.
• Ability to move around the lab repeatedly throughout the day, including being on feet for extended periods of time.

Qualifications: BA in Chemistry (Biological Focus) with 1 year of Experience

• Good understanding of microbiological testing techniques gained through practical experience.
• Good understanding of environmental testing gained through practical experience.
• Experience in validation of test methods, cleaning procedures, and production processes.
• Experience with physical and chemical testing techniques.
• Experience of working within a GLP and GMP environment.
• Proactive approach to problem-solving and commitment to achieving quality results on schedule.
• Proven ability to conduct experiments according to standard operating procedures and develop new standard operating procedures.
• Excellent written and verbal communication skills, and proven ability to work collaboratively with interdisciplinary teams.
• Ability to work in a team environment.
• Proven ability to train less experienced staff.

Qualifications: BS in Forensic Science (Biology Track) with 5 years of Experience

• Experience in a laboratory setting
• Experience in food/pharmaceutical/nutraceutical processing operations, FDA-regulated industry.
• Excellent technical, written, organizational, critical thinking/analytical, problem-solving/troubleshooting, and communication/interpersonal skills.
• Proficient in aseptic techniques, sterilization, safe microbiology, and general lab practices.
• Strong computer skills, including keyboarding and working knowledge of MS Office.
• Strong decision-making skills and a logical approach to resolving job-related challenges.
• Ability to meet deadlines.
• Ability to work independently and in a team environment.
• Ability to maintain a positive, professional, cooperative demeanor.
• Ability to foster productive working relationships with management, coworkers, vendors, and customers.

Qualifications: BS in Pharmaceutical Sciences with 3 years of Experience

• Experience working in a BSL-3 laboratory environment.
• Willingness to work in the BSL3 laboratory, along with a calm mindset, organization skills, adjusting to changes, and the ability to maintain stamina throughout the workday.
• Experience with microbiology techniques, including preparing media, plating bacteria, propagation, and identification.
• Experience working within an ISO:9001-compliant environment
• Knowledge and/or experience in a research environment, with basic analytical skills, sample preparation, and analysis.
• Experience with bioanalytical methods.
• Good PC skills and the ability to learn new software and systems.
• Ability to effectively communicate and interact with technical staff at all levels in a team-based environment.
• Adept time management skills, ability to work under pressure, multitask, and be flexible.
• Proficient oral and written communication skills.
• Detail-oriented and have the ability to work independently.
• Can maintain a laboratory notebook and prepare raw data for submission to the supervisor.

Qualifications: BA in Natural Sciences (Biology Concentration) with 2 years of Experience

• Knowledge of food microbiology test methods and method qualification.
• Proficient knowledge of food microbiology, cleaning and sanitizing applications in low-moisture food environments, and sanitary design of equipment and facilities.
• Proficient in reviewing, understanding, and interpreting microbiological data.
• Ability to collect relevant information, identify trends and patterns, and communicate.
• Ability to identify, define, and analyze problems to determine root causes and identify possible solutions.
• Proficient in developing and presenting business presentations to Senior Management.
• Excellent interpersonal and communication skills (written and verbal).
• Proficient Knowledge of HACCP, preventive controls, and cGMPs.
• Proficient in reviewing, understanding, and interpreting microbiological data.
• Excellent ability to multitask and prioritize duties.
• Proficient in computer skills, including Microsoft Office (Word, Excel, and PowerPoint) and SAP.
• Ability to perform data analysis utilizing Microsoft Excel, Google Sheets, Tableau, or equivalent software applications.
• Excellent project management skills.

Qualifications: BS in Food Science with 6 years of Experience

• Experience in method transfer and verification/validation.
• Experience in statistical analysis, including the use of Minitab.
• General knowledge of pharmaceutical plasma-derivative company processes, equipment, and their microbiological control.
• Strong knowledge of analytical techniques for biologics or protein-based therapeutics.
• Excellent verbal and written communication skills.
• Must have strong technical writing skills.
• Strong interpersonal skills with the ability to interact with all levels of personnel professionally.
• Strong organizational, analytical, and problem-solving skills.
• Ability to analyze details and perform structured decision-making daily.

Qualifications: BS in Medical Laboratory Science with 4 years of Experience

• Relevant experience in a Microbiology laboratory.
• Experience in a Pharmaceutical environment.
• Working knowledge of cGMPs, GLP, FDA guidelines, USP, EP, and other applicable industry regulatory requirements.
• Experience in microbiological testing in a pharmaceutical microbiology Lab.
• Experience with Laboratory Information Management Systems (LIMS).
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management, and other internal stakeholders.
• Self-directed with the ability to plan, organize, and prioritize work.
• Capable of scheduling, planning, and working independently.
• Detail-oriented with the ability to identify errors and/or inconsistencies while performing tasks.

Qualifications: BA in Health Sciences (Biology Emphasis) with 3 years of Experience

• Previous Microbiology experience.
• Ability to read, speak, and understand the English language.
• Basic reading, math, and computer (Microsoft Office) skills.
• Quality experience in a manufacturing environment, preferably in dietary supplements, food, or beverages.
• Working knowledge of cGMP regulations.
• Strong oral and written communication skills
• Ability to follow written and verbal instructions/procedures.
• Strong attention to detail and time management skills
• Ability to multitask in a deadline-focused culture
• Ability to work in a team-based environment with minimal day-to-day direction.
• Demonstrated critical thinking, problem-solving, and analytical skills.
• Self-governing/self-starter, takes initiative.

Qualifications: BS in Pathobiology with 2 years of Experience

• Previous experience in a microbiology environment.
• Experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, identification and characterization, testing of medical devices, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls.
• Excellent computer skills in the usage of MS Office and the Analytical Equipment System.
• Excellent problem-solving and critical thinking skills.
• Full knowledge and understanding of Edwards' policies and procedures relevant to microbiology.
• Full knowledge and understanding of microbiology principles, theories, and concepts.
• Expertise in one of the following areas: sterilization process, final release testing, and environmental controls.
• Excellent written and verbal communication skills.
• Advanced problem-solving skills and strict attention to detail.
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others, as well as to the protection of the environment and prevention of pollution under their span of influence/control.
• Ability to manage competing priorities in a fast-paced environment.

Qualifications: BA in Microbiology with 6 years of Experience