Senior Equipment Process Engineer- Downstream

Sanofi • Framingham, MA

2d

About The Position

The Senior Equipment Process Engineer – Downstream is the technical owner for an assigned portfolio of manufacturing, utility, facility, or laboratory equipment. The role improves equipment safety, compliance, availability, and lifecycle performance through hands-on troubleshooting, maintenance strategies, equipment changes, technical documentation, and cross-functional leadership. The position is based in Framingham, Massachusetts.

The engineer owns equipment performance and lifecycle planning, leads field troubleshooting and maintenance readiness, and supports equipment modifications and new assets from technical requirements through turnover. The role also drives reliability improvements and ensures equipment-related quality actions and records are complete, traceable, and inspection-ready.

Requirements

• Bachelor's degree in mechanical, electrical, chemical, biomedical, or a 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, preventive maintenance 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.

Nice To Haves

• Experience in biopharmaceutical, pharmaceutical, medical-device, single-use technology (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.

Responsibilities

• Maintain equipment asset health, design basis, operating limits, criticality, failure history, documentation, maintenance strategy, obsolescence risks, and improvement priorities.
• Diagnose complex mechanical, electrical, instrumentation, and control-interface issues, partnering with mechanics and technicians through repair, testing, and return to service.
• Develop and technically approve complete, executable work packages covering scope, sequence, labor, parts, tools, permits, LOTO, acceptance criteria, post-maintenance testing, and restoration requirements.
• Develop risk-based preventive maintenance strategies, equipment bills of materials, critical-spares lists, stocking recommendations, and obsolescence mitigation plans.
• Lead equipment changes and projects, including technical requirements, design reviews, vendor selection, FAT/SAT, commissioning, qualification, turnover, training, maintenance readiness, and documentation.
• Lead equipment-specific change controls and CAPAs, provide timely deviation assessments, and ensure hardware changes are implemented, tested, documented, and effectively closed.
• Use downtime, repeat work, deviations, maintenance findings, and condition data to improve reliability, maintainability, safety, and compliance and eliminate bad actors.
• Develop technical scopes, assess vendor capability and performance, and collaborate with Operations, Quality, Validation, Metrology, HSE, Automation, Engineering, Procurement, Stores, and Finance.
• Deliver schedule-ready work packages and maintenance master data, risk-based PM programs, accurate equipment BOMs, and critical-spares strategies.
• Reduce repeat failures, emergency work, avoidable downtime, and exposure to obsolete components.
• Provide complete maintenance readiness and technical turnover for equipment changes and new assets.
• Maintain accurate, traceable, inspection-ready drawings, specifications, manuals, and records.

Benefits

• Health and wellbeing benefits, including healthcare and prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employees may be eligible to participate in company employee benefit programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior