Engineer (Utilities)

Clean Utilities SME Engineer Contract type: Fixed- Term, 23-months About Sanofi: Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. The Senior Clean Utilities Specialist/SME is the site's technical authority for all critical utility systems supporting GMP manufacturing — including Purified Water (PW), Water for Injection (WFI), Clean Steam (CS), and cleanroom HVAC. This is a hands-on technical expert role responsible for system design integrity, troubleshooting complex technical issues, ensuring regulatory readiness, and driving continuous improvement and innovation across the site's clean utilities infrastructure. System Design & Engineering Lead technical design reviews for new installations, upgrades, and modifications to PW, WFI, CS, and HVAC systems Develop User Requirement Specifications (URS) and technical specifications for capital projects Troubleshooting & Root Cause Analysis Serve as the site's escalation point for complex technical failures across all clean utility systems Lead root cause investigations and develop robust CAPAs for unplanned utility disruptions, excursions, or EM/chemical/endotoxin deviations Apply advanced troubleshooting techniques (trend analysis, failure mode analysis) to prevent recurrence Regulatory Compliance & Audit Support Act as key SME during regulatory inspections and internal/external audits for critical utility systems Ensure ongoing compliance with Pharmacopoeial standards for water and steam quality Drive continuous improvement initiatives to reduce downtime, extend asset life, and improve system robustness Partner with Reliability Engineering and Planning & Scheduling teams to optimize maintenance strategies Evaluate and pilot emerging technologies for clean utilities applications Champion digitalization of monitoring, alarming, and data trending for critical systems Provide technical mentorship and training to maintenance technicians and junior engineers Represent clean utilities in cross-functional project teams (Quality, Validation, Production, EHS) Contribute site expertise to network/global technical forums and best-practice sharing Evaluate and select equipment vendors and service providers for clean utilities systems Manage technical relationships with OEMs and service contractors; assess new technology solutions during capital planning Bachelor’s degree in engineering (Mechanical, Chemical, or related) or equivalent technical qualification ~7+ years of experience operating and troubleshooting GMP critical utility systems in pharmaceutical, biotech, or comparable high-purity manufacturing (semiconductor, food/beverage) ~ Experience supporting regulatory audits/inspections as a technical SME ~ Familiarity with emerging digital/PAT technologies is a plus ~ GMP Compliance, Energy Engineering, Utility Systems Design, Project management, Preventative and Corrective Maintenance, RCA and CAPA development Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally  Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave  #