QC Microbiology / Sterility Technician

We are looking for an experienced QC Microbiology Technician, with practical experience in sterility testing under isolator in a Grade A environment.

Experience in sterility, aseptic handling and working under a Grade A isolator is an essential prerequisite for this position.

Within the QC Microbiology laboratory, you will play a key role in ensuring the microbiological quality and compliance of biological products, Drug Substance (DS) and Drug Product (DP), in a demanding GMP pharmaceutical environment.

You will be involved particularly in sterility tests under isolator, as well as Bioburden, LAL analyses and environmental monitoring. You will also contribute to investigations, method validations, continuous improvement activities and laboratory projects.

Your main duties

Sterility tests & work under Grade A isolator

• Independently perform sterility tests under Grade A isolator on products from aseptic filling processes.
• Carry out the various steps of preparation, transfer and handling of samples in strict compliance with aseptic techniques and GMP procedures.
• Ensure compliance with contamination control requirements and activities performed in a sterile environment.
• Participate in the operational management of the isolator and maintain its qualified status.
• Identify and report any anomaly likely to impact sterility, test integrity or result quality.

QC Microbiological analyses

• Perform routine microbiological analyses necessary for batch release: Bioburden and LAL.
• Carry out sampling and analyses related to environmental and utilities monitoring: PV, PNV, TOC, Bioburden, LAL.
• Ensure critical review of raw data, calculations and analytical results.
• Guarantee traceability of operations and strict compliance with GMP and Data Integrity requirements.

Technical expertise & method validation

• Participate in the verification and validation of microbiological methods, notably Bioburden and LAL.
• Contribute to activities related to the introduction of new products and method transfers.
• Provide your technical expertise on microbiological and sterility issues encountered in the laboratory.
• Participate in automation, digitalisation and laboratory efficiency improvement projects.

Deviations & investigations

• Manage deviations, OOS/OOT and non-conformities related to microbiological and sterility activities.
• Conduct investigations using structured Root Cause Analysis methodologies.
• Define and implement relevant CAPA in collaboration with QA, Production, Engineering and Validation teams.
• Participate in trend analysis and continuous improvement of QC Microbiology processes.

Documentation & equipment

• Write and update SOPs, work instructions, protocols and QC reports.
• Participate in qualification, monitoring and maintenance of laboratory equipment.
• Contribute to the introduction and qualification of new equipment and consumables.

Your profile

Essential prerequisites

• Training in microbiology, biology, biotechnology or equivalent scientific field – CFC or higher education.
• Minimum 5 years’ experience in QC microbiology in the pharmaceutical or biotechnological industry, in a GMP environment.
• Practical and recent experience of sterility testing under Grade A isolator – essential.
• Excellent command of aseptic techniques and handling in sterile environments.
• Good understanding of GMP requirements associated with sterility and contamination control activities.

Additional desired skills

• Practical experience of Bioburden and LAL analyses.
• Experience in environmental and utilities monitoring.
• Experience in validation or verification of microbiological methods.
• Good command of deviation investigations, Root Cause Analysis and CAPA.
• Experience in an aseptic production environment is a real asset.

Personal skills

You are recognised for your rigour, autonomy and critical thinking. Comfortable in a demanding GMP environment, you can quickly identify deviations and work effectively with different functions. You appreciate teamwork while being able to manage your activities autonomously and proactively.

Languages & availability

• French: fluent / native language.
• English: good professional level.
• Flexibility to occasionally work weekends or outside standard hours, according to production and control activity needs.