Qualification engineer - South of France
The Qualification Engineer will be responsible for executing and overseeing qualification activities (IQ, OQ, PQ) across critical manufacturing and utility systems. The role involves planning, documentation, troubleshooting, and cross‑functional collaboration to ensure compliance with GMP standards and successful system validation.
This position requires fluent French language skills, full rights to work in France/EU, and full‑time on‑site presence.
Key Responsibilities
- Participate in SAT execution and review SAT reports.
- Full qualification execution (IQ, OQ, PQ) for systems including:
- Manufacturing equipment (Filter‑Dryer, vessel skids with agitation/pumping, etc.)
- Cold/freezer rooms
- Unidirectional flow hoods
- Purified Water System
- Nitrogen System
- Cleanroom classification
- Prepare execution planning, ensuring availability of measuring instruments, sampling systems, raw materials, and team members in line with protocols.
- Gather and organize all relevant documentation (FAT, SAT, supplier documentation) for IQ/OQ activities.
- Identify and troubleshoot technical issues during qualification, proposing effective solutions to prevent non‑conformities.
- Conduct IQ, OQ, and PQ execution in collaboration with production, maintenance, and QC teams.
- Collect and document test results in protocols, identify non‑conformances, and escalate findings as required.
- Provide technical support and guidance to other members of the qualification team.
Qualifications & Skills
- Strong knowledge of GMP requirements and qualification methodologies (IQ, OQ, PQ).
- Experience with manufacturing equipment, cleanroom environments, and utility systems.
- Ability to interpret FAT/SAT documentation and supplier technical files.
- Problem‑solving mindset with capability to troubleshoot and resolve technical issues.
- Excellent organizational skills with attention to detail in planning and documentation.
- Effective communicator with cross‑functional teams (production, maintenance, QC).
- Team‑oriented, with willingness to support colleagues in qualification activities.
- Fluent French language skills.
- Full rights to work in France/EU.
- Ability to work full‑time on site.
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