Jobs · Management · Massachusetts

Senior Equipment Process Engineer- Downstream

BioSpace · Framingham, MA · Today
ManagementFull-time

About the role

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.

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving peoples 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.

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.

Requirements

  • 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 Qualifications

  • 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.

Benefits

  • Thoughtful, well-crafted rewards package that recognizes contribution and amplifies impact.
  • Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.
  • At least 14 weeks gender-neutral parental leave.
  • Endless opportunities to grow talent and drive career, whether through promotion or lateral move, at home or internationally.
  • 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.

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