Site Microbiologist / Plant Microbiologist

Position Summary

The Site Microbiologist provides technical leadership and oversight for microbiological control across pharmaceutical operations in a GMP-regulated environment. The role serves as the site subject matter expert for microbial contamination control, microbial impact assessments, investigation support, quality risk assessments, technical documentation, equipment and system reviews, and inspection readiness. The position partners with Quality, Manufacturing, Engineering, Validation, and other site functions to ensure robust microbial control strategies, scientifically sound decision-making, and sustained regulatory compliance.

Key Responsibilities

· 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.

· Lead microbial impact assessments: Assess potential microbial impact on processes, products, facilities, utilities, equipment, and operations, and recommend scientifically justified risk-mitigation actions.

· 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.

· Strengthen technical documentation: Author, review, or update microbiology-related technical documents, procedures, cross-contamination control strategies, change-control impact assessments, and supporting technical rationales.

· Perform quality risk assessments: Evaluate likelihood, severity, detectability, and control effectiveness for microbiological risks, and translate risk outputs into practical risk-control strategies.

· 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.

· 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.

· 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

· Bachelor’s degree or above in microbiology, environmental microbiology, medical microbiology, food microbiology, pharmaceutical sciences, biotechnology, or related scientific discipline.

· 7-10 years of relevant experience in plant microbiology, pharmaceutical microbiology, biotechnology manufacturing, food microbiology, or another regulated manufacturing environment.

· Strong understanding of microbiological principles, microbial contamination control, environmental monitoring, microbial risk assessment, and GMP expectations in a manufacturing environment.

· Practical experience supporting investigations, root cause analysis, CAPA definition, technical documentation, and inspection of readiness activities.

· Working knowledge of EU GMP Annex 1 expectations and their practical application to sterile manufacturing, contamination control, or microbiological control programs.