The QC Microbiology 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 7 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.
Skills / Competencies:
- 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.