Job :
You will ensure the reliable execution of microbiological analyses of raw materials, in-progress products, and finished products, as well as the microbiological monitoring of production environments, in strict compliance with regulatory requirements (GMP, Pharmacopoeias, ISO).
Key responsibilities
- Perform microbiological analyses: germ counts, search for specific germs, sterility tests, endotoxins (LAL).
- Ensure microbiological control of water, air, surfaces, and personnel.
- Prepare and check culture media (sterility, fertility).
- Perform tests according to validated methods (Ph. Eur., USP, ISO).
- Ensure traceability of samples and results (LIMS).
- Perform environmental monitoring of production areas (class D) and analyze trends.
- Participate in OOS/OOT investigations, CAPAs, and SOP updates.
- Contribute to the maintenance, qualification, and metrology of laboratory equipment.
- Strictly apply HSE, hygiene, and biological safety rules.
Required profile :
- Education: Bachelor's degree +3 in microbiology, biology, biotechnology, or pharmacy.
- Experience: Minimum 3 years in a pharmaceutical or food industry laboratory in a GMP environment.
- Technical skills: membrane filtration, seeding, incubation, LAL, microbial identification.
- Knowledge: GMP, European Pharmacopoeia, ISO 17025.
- Tools: LIMS, Excel, microbiological monitoring software.
- Languages: fluent French
- Qualities: rigor, organizational skills, teamwork, responsiveness, and adherence to procedures.