(Senior) C&Q Engineer

<p><b>About the job</b></p><p>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.<br /> </p><p>As a (Senior) C&amp;Q Engineer, you will be responsible for driving excellence across the following key areas:</p><p></p><p><b>C&amp;Q Strategy &amp; Execution</b></p><ul><li><p>Develop and execute qualification protocols (IQ, OQ, PQ) for facilities, utilities, and equipment, inclusive of associated automation qualification</p></li><li><p>Leverage and build upon the established C&amp;Q strategy and framework from the Greenfield project, adapting and extending it for Tier 3 project requirements</p></li><li><p>Apply global C&amp;Q approaches to site-specific Tier 3 project needs while ensuring compliance with GMP, FDA, and other applicable regulatory requirements</p></li></ul><p></p><p><b>Project Delivery</b></p><ul><li><p>Drive end-to-end C&amp;Q delivery for Tier 3 capital projects, encompassing design, execution, qualification, handover, and close-out phases</p></li><li><p>Coordinate and oversee C&amp;Q external contractors in executing project scope, ensuring quality standards, timeline adherence, and deliverable completion</p></li><li><p>Work closely with Project Leads to integrate C&amp;Q activities into overall project schedules, milestones, and critical path planning</p></li><li><p>Provide C&amp;Q technical input during project stage gate reviews and support site decision-making through recommendations and risk assessments</p></li></ul><p></p><p><b>Technical Expertise</b></p><ul><li><p>Serve as the key C&amp;Q technical resource during quality-related discussions, audits, and inspections</p></li><li><p>Lead investigations and develop CAPAs for qualification-related deviations or non-conformances</p></li><li><p>Identify improvement opportunities for qualification processes and critical systems</p></li><li><p>Implement process improvements to enhance efficiency, safety, and quality of C&amp;Q activities</p></li></ul><p></p><p><b>Documentation &amp; Compliance</b></p><ul><li><p>Manage C&amp;Q digital platforms and electronic documentation management systems, ensuring optimal functionality, user access management, and continuous improvement</p></li><li><p>Develop, review, and approve qualification documentation including protocols, reports, and summary reports in accordance with regulatory standards</p></li><li><p>Ensure all C&amp;Q documentation meets data integrity requirements (ALCOA&#43; principles) and complies with regulatory standards</p></li></ul><p></p><p><b>Collaboration &amp; Communication</b></p><ul><li><p>Participate actively in Communities of Practice (COPs) and global expert networks to exchange best practices, drive innovation, and stay current with C&amp;Q industry trends</p></li><li><p>Contribute lessons learned, share technical insights, and co-develop solutions with global peers to advance C&amp;Q excellence</p></li><li><p>Support global C&amp;Q initiatives and collaborate across regions to standardize approaches and improve efficiency</p></li></ul><p></p><p><b><u>Candidate Profile</u></b></p><p></p><p><b>Qualifications</b></p><ul><li><p>Bachelor&#39;s degree or higher in Engineering (Chemical, Mechanical, Electrical, or related discipline)</p></li><li><p>Minimum 6–10 years of experience in Commissioning &amp; Qualification within the pharmaceutical, biotechnology, or related GMP-regulated industry</p></li><li><p>Proven hands-on experience with IQ, OQ, PQ protocols for facilities, utilities, and equipment in a manufacturing environment</p></li></ul><p></p><p><b>Technical Competencies</b></p><ul><li><p>Strong working knowledge of GMP, FDA, EMA, and other relevant regulatory requirements</p></li><li><p>Proficiency in data integrity principles (ALCOA&#43;) and their application in C&amp;Q documentation</p></li><li><p>Experience with C&amp;Q digital platforms and electronic documentation management systems</p></li><li><p>Familiarity with HVAC, clean utilities, process equipment, and cleanroom qualification</p></li></ul><p></p><p><b>Project &amp; Delivery Experience</b></p><ul><li><p>Demonstrated ability to independently manage C&amp;Q scope for capital projects from design through to handover and close-out</p></li><li><p>Track record of coordinating and overseeing external contractors to deliver on quality, schedule, and budget</p></li><li><p>Experience integrating C&amp;Q activities into broader project schedules and critical path planning</p></li><li><p>Exposure to project stage gate processes and risk assessment methodologies</p></li></ul><p></p><p><b>Soft Skills &amp; Leadership Potential</b></p><ul><li><p>Self-starter with the ability to hold the fort independently and take full ownership of C&amp;Q deliverables with minimal supervision</p></li><li><p>Strong problem-solving and investigation skills, with a proactive approach to identifying and resolving issues</p></li><li><p>Excellent communication and stakeholder management skills, able to engage confidently with internal teams, contractors, and regulatory bodies</p></li><li><p>Collaborative mindset with a willingness to contribute to global networks and communities of practice</p></li><li><p>Demonstrated leadership qualities and a desire to grow into a people management role</p></li></ul><p></p><p><b>Preferred (Good to Have)</b></p><ul><li><p>Experience in Greenfield or large-scale capital project environments</p></li><li><p>Prior involvement in site expansions, or Tier 3 (&lt;5mil €) projects</p></li><li><p>Professional certifications in project management (e.g., PMP) or quality (e.g., ASQ CQE) would be advantageous</p></li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>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.</p><p></p><p>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.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p>