Senior Equipment Process Engineer- Downstream

Job Title: Senior Equipment Process Engineer- Downstream

• Location: Framingham, MA

About the Job

The Senior Equipment Process Engineer- Downstream is the technical owner for an assigned portfolio of manufacturing, utility, facility, or laboratory equipment. This role improves equipment safety, compliance, availability, and lifecycle performance by combining hands-on troubleshooting with effective maintenance strategies, equipment changes, technical documentation, and cross-functional leadership.

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. 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 lives.

Main Responsibilities

• Own equipment performance and lifecycle: Maintain asset health, design basis, operating limits, criticality, failure history, documentation, maintenance strategy, obsolescence risks, and improvement priorities.

• Lead troubleshooting and field support: Diagnose complex mechanical, electrical, instrumentation, and control-interface issues. Partner directly with mechanics and technicians through repair, testing, and return to service.

• Build executable maintenance plans: Develop and technically approve complete work packages, including scope, sequence, labor, parts, tools, permits, LOTO, acceptance criteria, post-maintenance testing, and restoration requirements.

• Optimize preventive maintenance and spares: Create risk-based PM strategies, equipment BOMs, critical-spares lists, stocking recommendations, and obsolescence mitigation plans using equipment criticality, failure modes, OEM guidance, and operating history.

• Lead equipment changes and projects: Define technical requirements and lead design reviews, vendor selection, FAT/SAT, commissioning, qualification, turnover, training, maintenance readiness, and documentation for modifications and new equipment.

• Own technical quality actions: Lead equipment-specific change controls and CAPAs, provide timely deviation assessments, and ensure approved hardware changes are implemented, tested, documented, and effectively closed.

• Drive reliability improvement: Use downtime, repeat work, deviations, maintenance findings, and condition data to eliminate bad actors and improve reliability, maintainability, safety, and compliance.

• Coordinate vendors and stakeholders: Develop technical scopes, assess vendor capability and performance, and collaborate with Operations, Quality, Validation, Metrology, HSE, Automation, Engineering, Procurement, Stores, and Finance.

Key Deliverables

• Technically complete, schedule-ready work packages and maintenance master data.

• Risk-based PM programs, accurate equipment BOMs, and critical-spares strategies.

• Timely, technically sound closure of deviations, CAPAs, change controls, and engineering actions.

• Reduced repeat failures, emergency work, avoidable downtime, and obsolete-component exposure.

• Complete maintenance readiness and technical turnover for equipment changes and new assets.

• Accurate, traceable, and inspection-ready drawings, specifications, manuals, and records.

About You

Basic Qualifications

• Bachelor's degree in mechanical, electrical, chemical, biomedical, or related engineering discipline.

• At least 3 years of engineering experience supporting manufacturing, facilities, utilities, laboratories, or complex process equipment in a regulated or high-reliability environment.

• Demonstrated equipment troubleshooting capability using drawings, manuals, data, failure history, and structured root-cause methods.

• Experience developing job plans, PM tasks, technical specifications, spare-parts recommendations, or maintenance strategies.

• Experience supporting equipment modifications, commissioning, qualification, change control, deviations, or CAPAs.

• Ability to work effectively in the field and communicate technical risk and recommendations to technical teams and leaders.

Preferred

• Experience in biopharmaceutical, pharmaceutical, medical-device, SUT, or other cGMP manufacturing.

• Working knowledge of CMMS/EAM systems, equipment BOMs, work-order controls, and maintenance master data.

• Knowledge of reliability methods, including criticality, FMEA, root cause analysis, condition monitoring, bad-actor elimination, and lifecycle planning.

• Experience with P&IDs, electrical and mechanical drawings, instrumentation, controls interfaces, and OEM technical packages.

• PE, CMRP/CRL, Lean/Six Sigma, project-management training, or related professional certification.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• 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.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.