Technician QC Microbiology

Aperçu Summary

The QC Microbiology Technician performs microbiology activities to support production and release of drug substance and drug product, including sterility testing of aseptically filled drug product (DP) using an isolator, as well as environmental and utilities monitoring and control in a GMP environment. In addition to routine testing, the QC Microbiology Technician contributes to microbiology method verifications/validations (e.g., Bioburden, LAL), performs review of data and documentation, and actively contributes to continuous improvement, laboratory automation initiatives, and laboratory investigations including root cause analysis. He/she also authors and maintains analytical and QC procedures and provides technical support to other team members.

Performs QC analysis to support production release of drug substance (Bioburden, LAL), ensuring right-first-time execution and documentation. Performs sterility testing of aseptically filled drug product (DP) using an isolator to support DP batch release, ensuring compliant aseptic manipulations, right-first-time execution, and accurate GMP documentation. Performs sampling and testing for environmental monitoring and utilities control (PV, PNV, Bioburden, LAL, TOC), including scheduling and prioritization when needed. Ensures adherence to GMP, data integrity requirements, safety rules, and internal quality standards. Executes microbiology method verification/validation activities (Bioburden/LAL and related methods): preparation, execution, documentation, and closure. Perform thorough review of analytical raw data, calculations, records and reports, including second-person review as applicable, ensuring completeness, traceability, data integrity, compliance, and timely reporting of results. Contributes actively to laboratory investigations, including structured root cause analysis and definition of robust CAPAs. Collaborates cross-functionally (Production, QA, Engineering, Validation, other QC functions) to support investigations and prevention of recurrence. Participates in improvement projects to increase lab efficiency, quality, and compliance. Contributes to laboratory digitalization/automation initiatives. Authors, reviews and maintains SOPs, Work Instructions, and other QC documentation. Supports change control activities related to methods/equipment/procedures. Supports management of QC consumables, reagents and standards. Supports maintenance/calibration of equipment. Acts as a role model for GMP behaviors, data integrity, and business ethics.

Degree in Microbiology (CFC or higher degree) with at least 5 years of experience in biotech, pharmaceutical environment, including QC Microbiology in a GMP setting. Proven hands-on experience with Bioburden and LAL testing, environmental monitoring and utilities control. Proven hands-on experience in sterility testing of aseptically filled drug product (DP) using an isolator, including aseptic manipulations, isolator operation, and associated GMP documentation. Strong knowledge of microbiology testing in GMP and of method verification/validation/transfer principles. Experience in data review (raw data, logbooks, calculations, reports) and in applying data integrity principles. Experience supporting deviation investigations, root cause analysis, and CAPA implementation. High autonomy and accountability; able to prioritize, anticipate issues, and propose solutions. Force of proposal / continuous improvement mindset; comfortable driving improvements and supporting automation/digitalization. Excellent team spirit and communication; able to collaborate cross-functionally. French: Native or Fluent English: Good knowledge Knowledge of most common office software.

Work conditions

Work on weekends and outside standard working hours may be required.