Senior Equipment Process Engineer- Upstream

Sanofi • Framingham, MA

2d

About The Position

The Senior Equipment Process Engineer – Upstream 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, effective maintenance strategies, equipment changes, technical documentation, and cross-functional leadership. The position is based in Framingham, Massachusetts.

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, 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.

Nice To Haves

• 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 a related professional certification.

Responsibilities

• Own equipment performance and lifecycle, including 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, and work with mechanics and technicians through repairs, testing, and return to service.
• Develop and technically approve complete, executable maintenance work packages covering scope, sequence, labor, parts, tools, permits, LOTO, acceptance criteria, post-maintenance testing, and restoration requirements.
• Create risk-based preventive maintenance strategies, equipment bills of materials, critical-spares lists, stocking recommendations, and obsolescence mitigation plans.
• Define technical requirements and lead design reviews, vendor selection, FAT/SAT, commissioning, qualification, turnover, training, maintenance readiness, and documentation for equipment modifications and new equipment.
• Lead equipment-specific change controls and CAPAs, provide timely deviation assessments, and ensure approved hardware changes are implemented, tested, documented, and effectively closed.
• Use downtime, repeat work, deviations, maintenance findings, and condition data to eliminate bad actors and improve reliability, maintainability, safety, and compliance.
• Develop technical scopes, assess vendor capability and performance, and collaborate with Operations, Quality, Validation, Metrology, HSE, Automation, Engineering, Procurement, Stores, and Finance.
• Deliver technically complete, schedule-ready work packages and maintenance master data; risk-based PM programs, accurate equipment BOMs, and critical-spares strategies; timely technical closure of quality and engineering actions; reduced repeat failures, emergency work, avoidable downtime, and obsolete-component exposure; complete maintenance readiness and technical turnover; and accurate, traceable, inspection-ready technical records.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks’ 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