Senior C&Q Engineer – Manufacturing & Supply

About the role

The (Senior) C&Q Engineer will lead commissioning and qualification activities for Sanofi’s Modulus manufacturing projects, ensuring facilities, utilities and equipment meet GMP, FDA and other regulatory standards. This role supports the design, execution, hand‑over and close‑out of Tier 3 capital projects within a modular, agile production environment.

Key responsibilities

• Develop and execute qualification protocols (IQ, OQ, PQ) for facilities, utilities and equipment, including automation qualification.
• Apply and extend the global C&Q strategy to Tier 3 projects while maintaining compliance with GMP, FDA and other regulations.
• Drive end‑to‑end C&Q delivery for capital projects, coordinating design, execution, qualification, hand‑over and close‑out phases.
• Manage external C&Q contractors, ensuring quality, timelines and deliverables.
• Provide technical input during project stage‑gate reviews, risk assessments and decision‑making.
• Lead investigations, develop CAPAs for qualification‑related deviations and identify process improvement opportunities.
• Maintain C&Q digital platforms and electronic documentation systems, ensuring ALCOA+ data integrity.
• Participate in global Communities of Practice, share lessons learned and support standardisation initiatives.

Required profile

• Bachelor’s degree or higher in Engineering (Chemical, Mechanical, Electrical or related).
• Significant experience in commissioning and qualification within a regulated pharmaceutical or biologics environment.
• Strong knowledge of GMP, FDA and other applicable regulatory requirements.
• Proven ability to manage complex projects and coordinate multidisciplinary teams.

Required skills

• Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocol development.
• GMP and FDA regulatory compliance.
• ALCOA+ data integrity principles.
• Digital documentation platforms and electronic documentation management systems.
• Automation qualification.
• Risk assessment and CAPA development.