Plant Microbiologist

Job Description:

The role reports to the Sr. Manager CoE Upstream Processing and partners closely with Operations, the Centre of Expertise (CoE), and Quality.

Key responsibility areas

A. Contamination Control Program (CCP) support for Operations.
Assesses procedure effectiveness, drives improvements, and ensures inspection readiness.

B. Leads contamination investigations, root cause analysis, and CAPA.
Ensures scientifically sound interpretation and investigation rigor, including:

• Leads or supports deep-dive analysis of contamination events (protocol review, sample/data assessment, interpretation, and validity of conclusions).
• Leads or supports remediation of relevant inspection observations.
• Performs contamination impact assessments for change controls and provides the Operations recommendation.
• Drives root cause identification and CAPA definition, implementation follow-up, and closure.
• Validates investigation outcomes and ensures appropriate scientific justification.
• Ensures effectiveness checks are completed to prevent recurrence and strengthen contamination control.

C. Translator of microbiological risk into operational controls.
supports microbiological risk assessment (facility and process), translates risks into practical controls, and supports practical execution of environmental monitoring (EM) and microbiological control strategies, including:

• EM program qualification (e.g., EMPQ), periodic review of alert/action limits, and investigation of EM deviations.
• Effectiveness of cleaning, disinfection, and sanitization strategy in Operations.
• Oversight of sterilization and filtration validation and routine execution monitoring.

D. Data trending, performance management, and continuous improvement.
Reports and trends contamination and leakage rates and other performance indicators; communicates insights and priorities to stakeholders; and drives risk-reduction improvements by identifying opportunities, challenging the status quo, and supporting implementation of sustainable microbiological controls.

E. Enabler of culture, qualification, and training in aseptic practices.
Executes the training curriculum for microbiological hygiene and contamination prevention.

F. Subject matter expert (SME) for contamination control.
Advises on facility and process design from a microbiological perspective and shares expertise with other sites and global stakeholders.

Minimum Qualifications and Drivers

• BSc in Microbiology, Biotechnology, Biology, Chemical Engineering, or similar (MSc preferred), or equivalent experience.
• Several years’ experience in GMP-regulated manufacturing (biopharmaceutical/sterile/aseptic preferred) in Microbiology, Manufacturing Science & Technology, QA, or Operations support.
• Demonstrated experience with contamination control concepts and environmental monitoring (EM program design/optimization, EM qualification such as EMPQ, sampling strategies, and trending).
• Working knowledge of relevant GMP expectations and guidance (e.g., EU GMP/EudraLex Annex 1; FDA aseptic processing guidance) and how to translate them into practical shop-floor controls.
• Proven investigation and problem-solving capability (root cause analysis, CAPA definition/follow-up; handling deviations/inspection observations with scientific rigor).
• Ability to interpret microbiological and process data, build meaningful metrics/KPIs, and communicate insights to stakeholders.
• Strong written and verbal communication skills in English; Dutch preferred.