Senior CQV Specialists

A major global pharmaceutical company is building a new state‑of‑the‑art facility in France, covering aseptic manufacturing and high‑performance clean utilities. To support the commissioning, qualification, and validation (CQV) program, the client is seeking experienced CQV Consultants with strong technical depth and the ability to operate in a French‑speaking environment.

French‑speaking candidates are strongly preferred due to daily coordination with local engineering teams, vendors, and site leadership.

Key Responsibilities

• Lead and execute CQV activities for assigned systems, including isolators, autoclaves, formulation and filling equipment, clean utilities (WFI, clean steam, PW), HVAC, and associated automation.
• Prepare, review, and execute CQV documentation: URS, DQ, FAT/SAT, IOQ, PQ, validation plans, traceability matrices, and summary reports.
• Support process validation (PPQ) in alignment with the site's global validation strategy.
• Conduct and facilitate risk assessments (FMEA, GxP impact assessments, component criticality).
• Collaborate closely with Engineering, QA, Operations, and Automation to ensure systems are delivered and qualified on schedule.
• Participate in vendor oversight, FAT/SAT execution, troubleshooting, and deviation resolution.
• Ensure compliance with EU GMP, Annex 1, Annex 15, data integrity expectations, and internal quality standards.
• Contribute to project planning, scheduling, and progress reporting for CQV workstreams.
• Support inspection readiness for both internal audits and regulatory authorities.

Required Experience

• Proven experience as a CQV Engineer/Consultant in pharma or biotech.
• Strong background in aseptic/sterile operations.
• Hands‑on experience with new facility builds, equipment start‑up, and large capital projects.
• Solid understanding of EU GMP, Annex 1, Annex 15, and validation lifecycle principles.
• Ability to produce high‑quality, inspection‑ready documentation.
• Comfortable working cross‑functionally in a fast‑moving project environment.
• Fluent French is strongly preferred; professional English required for documentation and global interfaces.

Nice to Have

• Experience with automation/CSV (SCADA, PLC, DCS) and equipment integration.
• Exposure to biologics, vaccines, or high‑potency manufacturing.
• Vendor management experience with isolator or filling line suppliers.
• Familiarity with GAMP 5, ASTM E2500, and risk‑based validation approaches.

Personal Attributes

• Clear communicator able to navigate French‑speaking technical discussions.
• Structured, detail‑oriented, and documentation‑driven.
• Proactive, hands‑on, and comfortable in a dynamic project environment.
• Strong stakeholder management and problem‑solving skills.

Why This Project

• Opportunity to contribute to one of France's most significant pharma expansions.
• Work with cutting‑edge sterile manufacturing technologies.
• Long‑term project with strong extension potential.
• High‑impact role shaping the site's readiness for commercial operations and regulatory approval.