Senior Microbiologist
We are seeking an experienced Microbiologist to support the start-up and operation of a new European manufacturing facility. This role focuses on ensuring compliance with relevant standards, overseeing daily laboratory operations, and managing environmental monitoring, product testing, sterilisation processes, equipment qualification and LIMS implementation.
Key Responsibilities
Laboratory & Department Setup
1. Establish the microbiology laboratory, including protocols for method validation, cleanroom qualification, equipment qualification, and cleaning/disinfectant validation.
2. Generate and maintain qualification documentation.
Testing & Compliance
3. Perform and oversee microbiological testing in collaboration with internal teams and contract labs.
4. Review, interpret, and approve laboratory results; prepare periodic microbial testing reports (monthly, quarterly, annual).
5. Ensure activities align with company procedures and relevant domestic/international standards.
Documentation & Continuous Improvement
6. Create and review microbiology procedures and technical documents.
7. Execute experimental studies and support special projects.
8. Support deviation handling (deviations, OOS, CAPA, NCMR), and manage environmental monitoring excursions and investigations.
Environment & Equipment Oversight
9. Support environmental monitoring of HVAC/cleanrooms, compressed air/gases, and water systems.
10. Conduct risk assessments for process and facility changes.
11. Coordinate facility and equipment maintenance activities.
12. Oversee qualification, calibration, and maintenance of laboratory equipment.
13. Support LIMS implementation and ongoing use.
General
14. Carry out additional laboratory-related tasks as required.
Qualifications & Experience
15. Bachelor's degree in Microbiology, Biology, or related discipline.
16. 3–5 years' microbiology experience in medical device, pharmaceutical, biopharmaceutical, or similar regulated industry.
17. Knowledge of relevant regulations and standards (., 21 CFR 820, ISO 13485, ISO 14644, ISO 11737, ISO 14971, EU/US Pharmacopeia).
18. Understanding of environmental monitoring systems and product sterilisation desirable.
19. Experience establishing laboratory functions, method validations, and equipment qualifications is an advantage.
20. Strong communication, collaboration, self-motivation, and project-driving capability.
Contract
21. This is a contract role initially with a view to a longer term permanent contract. It may also suit a subcontractor who can offer their services on a shorter term basis (minimum 6 months)
22. Competitive rates on offer for an experienced candidate
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