CQV Engineer - GMP Capital Project Contractor (Lyon)

EPM Scientific; Lyon; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

The Freelance CQV Engineer role in Lyon, France, is for a capital project at a pharmaceutical facility. The consultant will deliver commissioning, qualification and validation activities across GMP utilities, equipment, process systems and supporting infrastructure, ensuring regulatory and project compliance.

Responsibilities include developing qualification documentation (DQ/IQ/OQ/PQ, risk assessments, traceability matrices, protocols) and coordinating field execution with Engineering,

Qualifications

• Minimum 5 years delivering CQV in GMP pharma/biotech environments.
• Knowledge of ISPE Guidance and EU GMP Annex 1.
• Experience executing IQ, OQ and PQ protocols.
• Ability to review engineering docs and P&IDs.
• Strong cross-functional collaboration and stakeholder management.

Responsabilités

• Execute CQV activities per project schedules and GMP requirements.
• Develop and review qualification docs (DQ/IQ/OQ/PQ, risk assessments, protocols, traceability matrices, reports).
• Coordinate field execution with Engineering, Operations, QA and vendors.
• Support FAT and SAT activities as needed.
• Review P&IDs, specs, datasheets and vendor docs.
• Turnover activities from construction through commissioning to operations.
• Collaborate with QA to ensure system release.
• Provide regular updates to CQV Lead and Project Management.

Connaissances

CQV activities

ISPE Guidance

EU GMP

Annex 1

IQ/OQ/PQ protocols

Description du poste

The Freelance CQV Engineer role in Lyon, France, is for a capital project at a pharmaceutical facility. The consultant will deliver commissioning, qualification and validation activities across GMP utilities, equipment, process systems and supporting infrastructure, ensuring regulatory and project compliance.

Responsibilities include developing qualification documentation (DQ/IQ/OQ/PQ, risk assessments, traceability matrices, protocols) and coordinating field execution with Engineering,