(Senior) C&Q Engineer

About the job

Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products.
 

As a (Senior) C&Q Engineer, you will be responsible for driving excellence across the following key areas:

C&Q Strategy & Execution

• Develop and execute qualification protocols (IQ, OQ, PQ) for facilities, utilities, and equipment, inclusive of associated automation qualification

• Leverage and build upon the established C&Q strategy and framework from the Greenfield project, adapting and extending it for Tier 3 project requirements

• Apply global C&Q approaches to site-specific Tier 3 project needs while ensuring compliance with GMP, FDA, and other applicable regulatory requirements

Project Delivery

• Drive end-to-end C&Q delivery for Tier 3 capital projects, encompassing design, execution, qualification, handover, and close-out phases

• Coordinate and oversee C&Q external contractors in executing project scope, ensuring quality standards, timeline adherence, and deliverable completion

• Work closely with Project Leads to integrate C&Q activities into overall project schedules, milestones, and critical path planning

• Provide C&Q technical input during project stage gate reviews and support site decision-making through recommendations and risk assessments

Technical Expertise

• Serve as the key C&Q technical resource during quality-related discussions, audits, and inspections

• Lead investigations and develop CAPAs for qualification-related deviations or non-conformances

• Identify improvement opportunities for qualification processes and critical systems

• Implement process improvements to enhance efficiency, safety, and quality of C&Q activities

Documentation & Compliance

• Manage C&Q digital platforms and electronic documentation management systems, ensuring optimal functionality, user access management, and continuous improvement

• Develop, review, and approve qualification documentation including protocols, reports, and summary reports in accordance with regulatory standards

• Ensure all C&Q documentation meets data integrity requirements (ALCOA+ principles) and complies with regulatory standards

Collaboration & Communication

• Participate actively in Communities of Practice (COPs) and global expert networks to exchange best practices, drive innovation, and stay current with C&Q industry trends

• Contribute lessons learned, share technical insights, and co-develop solutions with global peers to advance C&Q excellence

• Support global C&Q initiatives and collaborate across regions to standardize approaches and improve efficiency

Candidate Profile

Qualifications

• Bachelor's degree or higher in Engineering (Chemical, Mechanical, Electrical, or related discipline)

• Minimum 6–10 years of experience in Commissioning & Qualification within the pharmaceutical, biotechnology, or related GMP-regulated industry

• Proven hands-on experience with IQ, OQ, PQ protocols for facilities, utilities, and equipment in a manufacturing environment

Technical Competencies

• Strong working knowledge of GMP, FDA, EMA, and other relevant regulatory requirements

• Proficiency in data integrity principles (ALCOA+) and their application in C&Q documentation

• Experience with C&Q digital platforms and electronic documentation management systems

• Familiarity with HVAC, clean utilities, process equipment, and cleanroom qualification

Project & Delivery Experience

• Demonstrated ability to independently manage C&Q scope for capital projects from design through to handover and close-out

• Track record of coordinating and overseeing external contractors to deliver on quality, schedule, and budget

• Experience integrating C&Q activities into broader project schedules and critical path planning

• Exposure to project stage gate processes and risk assessment methodologies

Soft Skills & Leadership Potential

• Self-starter with the ability to hold the fort independently and take full ownership of C&Q deliverables with minimal supervision

• Strong problem-solving and investigation skills, with a proactive approach to identifying and resolving issues

• Excellent communication and stakeholder management skills, able to engage confidently with internal teams, contractors, and regulatory bodies

• Collaborative mindset with a willingness to contribute to global networks and communities of practice

• Demonstrated leadership qualities and a desire to grow into a people management role

Preferred (Good to Have)

• Experience in Greenfield or large-scale capital project environments

• Prior involvement in site expansions, or Tier 3 (<5mil €) projects

• Professional certifications in project management (e.g., PMP) or quality (e.g., ASQ CQE) would be advantageous

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!