Senior Equipment Process Engineer- Downstream

Sanofi•Framingham, MA

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 engineer owns equipment performance and lifecycle planning, leads complex troubleshooting and field repairs, develops and approves executable maintenance plans, and optimizes preventive maintenance and spare-parts strategies. The role also leads equipment modifications and projects from requirements and design reviews through commissioning, qualification, turnover, and training; owns equipment-specific quality actions; and drives reliability improvement using operating, maintenance, and condition data. The position coordinates vendors and collaborates with Operations, Quality, Validation, Metrology, HSE, Automation, Engineering, Procurement, Stores, and Finance. Key deliverables include schedule-ready work packages, risk-based PM programs, accurate equipment BOMs and spares strategies, timely closure of quality actions, reduced repeat failures and downtime, maintenance readiness for new or modified assets, and complete, traceable, inspection-ready technical records.

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 information, 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 support mechanics and technicians through repair, testing, and return to service.
Develop and technically approve complete maintenance work packages, including scope, sequence, labor, parts, tools, permits, LOTO, acceptance criteria, post-maintenance testing, and restoration requirements.
Develop risk-based preventive maintenance strategies, equipment BOMs, critical-spares lists, stocking recommendations, and obsolescence mitigation plans.
Lead equipment modifications 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 eliminate bad actors and improve reliability, maintainability, safety, and compliance.
Develop technical scopes, assess vendor capability and performance, and coordinate with Operations, Quality, Validation, Metrology, HSE, Automation, Engineering, Procurement, Stores, and Finance.
Maintain technically complete, schedule-ready work packages and maintenance master data.
Ensure maintenance readiness and technical turnover for equipment changes and new assets, and maintain accurate, traceable, inspection-ready drawings, specifications, manuals, and records.