Process Microbiologist

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Summary

The Plant Microbiologist owns and integrates contamination control within operations by translating microbiological risks into practical controls investigations and continuous improvement programs across the plant.

The role reports to the Sr. Director Biotherapeutics Operations and partners closely with Operations the Centre of Expertise (CoE) and Quality. The position has no direct reports but provides dotted-line leadership to operations project leads and the Contamination Prevention Team serving as the single point of contact (SPOC) for contamination control in Operations.

Key responsibility areas

Contamination Control Program (CCP) ownership for Operations.
Owns CCP implementation within Operations: authors and maintains CCP documents/SOPs assesses program effectiveness drives improvements and ensures inspection readiness. Approves CCP-related procedures and takes decisions in operations control (e.g. batch continuation processing deviations). Scientific lead for 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.

Translator of microbiological risk into operational controls.
Owns the Operations microbiological risk assessment (facility and process) translates risks into practical controls and oversees 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.

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. Enabler of culture qualification and training in aseptic practices.
Responsible for contamination control qualification (e.g. gowning aseptic handling welding) assessment and role-based training aligned with applicable GMP guidance (e.g. EU GMP/EudraLex Annex 1 and FDA aseptic processing guidance). Owns the training curriculum for microbiological hygiene and contamination prevention. 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

Minimum qualifications

• 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.

Drivers (what makes someone successful in this role)

• Strong ownership mindset: takes accountability for contamination control outcomes and inspection readiness.
• Influence without authority: can align operators supervisors QA and CoE on risk-based decisions and practical controls.
• Pragmatic risk translator: turns microbiological risk and regulatory expectations into clear usable procedures visual standards and operator behaviors.
• Coaching and training orientation: enjoys building capability through curriculum design hands-on coaching and knowledge transfer across layers.
• Continuous improvement drive: challenges the status quo uses data to prioritize and sustains gains through robust systems and follow-up.
• Resilience under pressure: remains calm during deviations investigations and inspections; makes timely decisions with incomplete data when needed.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.