QC Microbiology Technician

About the role

The QC Microbiology Technician supports the release of drug substances and drug products by performing microbiology testing in a GMP environment. The role includes sterility testing using an isolator, environmental monitoring, and method verification activities.

Key responsibilities

• Perform QC analysis for drug substance release, including Bioburden and LAL testing, ensuring right‑first‑time execution and proper documentation.
• Conduct sterility testing of aseptically filled drug product using an isolator, maintaining aseptic technique and accurate GMP records.
• Execute environmental and utilities monitoring (PV, PNV, Bioburden, LAL, TOC), schedule sampling and prioritize tasks as needed.
• Carry out microbiology method verification/validation, prepare documentation, and close out studies.
• Review raw data, calculations, and reports for completeness, traceability, and data integrity, providing second‑person review when required.
• Participate in investigations, root‑cause analysis, and CAPA definition, collaborating with Production, QA, Engineering and other QC functions.
• Support laboratory automation, digitalisation projects, SOP authoring, change control, consumables management and equipment maintenance.

Required profile

• Degree in Microbiology (CFC or higher) with at least 5 years of QC experience in a biotech/pharmaceutical GMP setting.
• Hands‑on experience with Bioburden, LAL, environmental monitoring and sterility testing using an isolator.
• Strong knowledge of GMP, method verification/validation principles and data‑integrity practices.
• Proven ability to conduct data review, deviation investigations and implement CAPA.
• High autonomy, proactive problem‑solving, and continuous‑improvement mindset.
• Fluent French and good English communication skills.

Required skills

• Bioburden testing
• LAL testing
• Sterility testing with isolator operation
• Environmental monitoring and utilities control
• Method verification and validation
• Data review and integrity assurance
• Deviation investigation and CAPA implementation