QC Microbiologist

Serovia USA Inc.; Branchburg Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Serovia USA Inc. seeks a QC Microbiologist to support environmental and microbiological control for a sterile pharmaceutical facility using isolator technology.

You will perform advanced testing, mentor junior staff, and ensure cGMP compliance with emphasis on data integrity and contamination control. The role supports startup, validation, and routine operations of the microbiology lab, contributing to sterility assurance for sterile IV bag products, with potential exposure to high-potent APIs.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Life Sciences, or related field.
• Minimum of 5 years of microbiology lab experience in a cGMP pharmaceutical or biotechnology manufacturing environment.
• Experience with isolator-based sterile manufacturing processes and aseptic support activities preferred.
• Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP <61>, <62>, <71>, <85>, <1116>, <788>).
• Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.
• Prior experience with high potent APIs and/or controlled substances desirable.
• Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.
• Strong documentation and data integrity skills with meticulous attention to detail.
• Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.
• Effective time management and prioritization skills in a fast-paced environment.
• Strong communication skills with the ability to train and mentor junior staff.
• Proactive, collaborative, and compliance-oriented mindset.
• Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.

Responsibilities

• Perform and oversee complex microbiological activities, including facility environmental monitoring and testing.
• Conduct and review microbiological testing for bioburden, bacterial endotoxin, sterility, and microbial identification on raw materials, in-process samples, and final products.
• Lead aseptic process simulations (media fills): planning, execution, incubation, and interpretation of results.
• Assist in startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.
• Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.
• Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.
• Mentor and provide technical guidance to junior microbiology staff, fostering scientific excellence and compliance.
• Maintain laboratory readiness for audits by following good laboratory practices and cGMP expectations.
• Participate in improvements to lab procedures, contamination control strategies, and sterility assurance programs.
• Interface with QA, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion.

Skills

Environmental monitoring

Data integrity

Sterility assurance

cGMP compliance

Documentation

Mentoring

Troubleshooting

Time management

Communication

Cross-functional collaboration

Education

Bachelor’s degree in Microbiology, Biology, Life Sciences

Tools

Isolator technology

Aseptic processing equipment

Sterilization cycle validation equipment

Laboratory equipment qualification

Job description

The QC Microbiologist will play a critical role in supporting the environmental and microbiological control program for a sterile pharmaceutical manufacturing facility utilizing isolator technology. This individual will perform advanced testing and monitoring activities, provide technical guidance to junior staff, and ensure that laboratory and aseptic processes comply with cGMP standards, with a strong emphasis on data integrity, contamination control, and sterility assurance. The position will support startup, validation, and routine operations of the microbiology laboratory, which supports the production of sterile injectable IV bag products including high potent and controlled substances.

Key Responsibilities:

• Perform and oversee complex microbiological activities, including facility environmental monitoring, utility sampling and testing (e.g., water, compressed gases), sterilization cycle validation, and aseptic process support in areas utilizing isolator technology.
• Conduct and review microbiological testing for bioburden, bacterial endotoxin, sterility, and microbial identification on raw materials, in-process samples, and final products.
• Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results.
• Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.
• Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.
• Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.
• Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.
• Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.
• Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.
• Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.

Qualifications / Experience:

• Bachelor’s degree in Microbiology, Biology, Life Sciences, or a related field.
• Minimum of 5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.
• Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.
• Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP <61>, <62>, <71>, <85>, <1116>, <788>).
• Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.
• Prior experience with high potent APIs and/or controlled substances is desirable.
• Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.
• Strong documentation and data integrity skills with a meticulous attention to detail.
• Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.
• Effective time management and prioritization skills in a fast-paced environment.
• Strong communication skills with the ability to train and mentor junior staff.
• Proactive, collaborative, and compliance-oriented mindset.
• Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.

Are you authorized to work in the United States? Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?

What is the highest level of education you’ve obtained? What is the highest level of education you’ve obtained?