Senior Equipment Process Engineer- Downstream

Sanofi•Framingham, MA
•$100,500 - $145,167

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, and supports Sanofi’s Manufacturing & Supply organization. The engineer collaborates with technical and operational groups to maintain asset health, execute equipment changes, improve reliability, and ensure equipment records and maintenance practices are 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, 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 partner with mechanics and technicians through repair, testing, and return to service.
  • Develop and technically approve complete work packages, including 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 hardware changes are implemented, tested, documented, and effectively closed.
  • Use downtime, repeat work, deviations, maintenance findings, and condition data to eliminate recurring equipment problems 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 closure of quality and engineering actions; reduced failures and downtime; maintenance readiness and technical turnover; and accurate, traceable, inspection-ready equipment records.

Benefits

  • Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
  • At least 14 weeks’ gender-neutral parental leave.
  • Company employee benefit programs; additional benefits information is referenced in the posting.
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