Commissioning & Qualification Engineer – Pharma (Vaccines)

About the role

We are seeking a Commissioning & Qualification (C&Q) Engineer to support vaccine production projects, both new builds and upgrades. The role ensures that all cGMP and validation activities are executed correctly, from design qualification through operational qualification and final validation reporting.

Key responsibilities

• Lead and coordinate commissioning and qualification activities for vaccine manufacturing equipment and utilities.
• Develop, review, and approve qualification protocols, raw data, and validation reports to ensure compliance with cGMP standards.
• Provide technical advice on deviations and issues to project stakeholders.
• Oversee qualification of HVAC systems, clean utilities (compressed air, steam, purified water, WFI), autoclaves, analytical systems, CIP/SIP processes, filling lines, and bulk equipment such as chromatography systems and fermentors.
• Ensure all GMP aspects are respected throughout the project lifecycle.
• Manage project timelines, coordinate contractors, engineering teams, and end‑users, and align activities with the overall project plan.

Required profile

• Proven success in C&Q coordination on pharmaceutical projects.
• Minimum 3 years of experience in commissioning and qualification within the pharma sector.
• Bilingual French/English (written and spoken).
• Strong understanding of injectable manufacturing processes and GMP practices (V‑cycle).
• Ability to work under pressure and within multidisciplinary, matrix‑organized teams.

Required skills

• Commissioning & Qualification methodology
• cGMP and Validation Master Plan
• Design Qualification, Installation Qualification, Operational Qualification, Validation Reporting
• HVAC systems qualification
• Clean utilities qualification (compressed air, steam, purified water, WFI)
• Autoclave and analytical systems qualification
• CIP/SIP process qualification
• Filling line and bulk equipment qualification (chromatography, fermentor)
• GMP practices (V‑cycle)
• Project planning and coordination
• French and English language proficiency