Site Microbiologist / Plant Microbiologist

Key Responsibilities

1. Serve as site microbiology SME: Act as the primary technical authority for microbiological questions, contamination control topics, and microbiology-related decision-making across site functions.
2. Lead microbial impact assessments: Assess potential microbial impact on processes, products, facilities, utilities, equipment, and operations, and recommend scientifically justified risk-mitigation actions.
3. Support investigations and RCA: Participate in microbial-related deviations and investigations, contribute to true root cause confirmation, and help define effective CAPA to prevent recurrence.
4. Strengthen technical documentation: Author, review, or update microbiology-related technical documents, procedures, cross-contamination control strategies, change-control impact assessments, and supporting technical rationales.
5. Perform quality risk assessments: Evaluate likelihood, severity, detectability, and control effectiveness for microbiological risks, and translate risk outputs into practical risk-control strategies.
6. Maintain inspection readiness:Support routine inspection readiness by ensuring microbiological practices, records, justifications, and site controls are technically sound and aligned with applicable regulatory and internal expectations.
7. Review equipment and systems: Assess the effectiveness of equipment, utilities, facilities, and monitoring systems used for microbial monitoring and control, and recommend improvements to prevent or detect microbial contamination.
8. Drive cross-functional capability: Provide coaching, consultation, and technical guidance to cross-functional teams on microbiological principles, aseptic and contamination-control concepts, and best practices.

Required Qualifications

1. Bachelor’s degree or above in microbiology, environmental microbiology, medical microbiology, food microbiology, pharmaceutical sciences, biotechnology, or related scientific discipline.
2. 7-10 years of relevant experience in plant microbiology, pharmaceutical microbiology, biotechnology manufacturing, food microbiology, or another regulated manufacturing environment.
3. Strong understanding of microbiological principles, microbial contamination control, environmental monitoring, microbial risk assessment, and GMP expectations in a manufacturing environment.
4. Practical experience supporting investigations, root cause analysis, CAPA definition, technical documentation, and inspection of readiness activities.
5. Working knowledge of EU GMP Annex 1 expectations and their practical application to sterile manufacturing, contamination control, or microbiological control programs.

Preferred Qualifications

1. Master’s degree or higher in microbiology or related discipline.
2. Experience in biologics, sterile manufacturing, aseptic processing, contamination control strategy, utilities monitoring, or environmental monitoring programs.
3. Experience interacting with internal auditors, customers, regulatory inspectors, or global quality teams.
4. Demonstrated ability to translate microbiological data and risk assessments into clear technical conclusions and practical site actions.