Sr. Equipment Process Engineer- Downstream

Sanofi Group; Framingham (MA); Presencial; USD 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Parental leave

Career growth opportunities

Descripción de la vacante

Sanofi is seeking a Sr. Equipment Process Engineer- Downstream in Framingham, MA to own and optimize the lifecycle of critical manufacturing and utility equipment.

You will lead troubleshooting, field support, and the creation of complete maintenance packages that align with cGMP expectations. You will drive PM strategies, spares planning, and equipment changes while coordinating with cross‑functional teams to ensure safe, compliant operations and timely project execution.

Formación

• Bachelor’s degree in mechanical, electrical, chemical, biomedical, or related engineering discipline with at least 3 years of relevant engineering experience in manufacturing, facilities, utilities, laboratories, or complex process equipment in a regulated or high‑reliability environment.
• Candidates without a bachelor’s degree must have at least 8 years of such experience.
• 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.

Responsabilidades

• 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.

Conocimientos

Troubleshooting equipment

Root cause analysis

Regulated CGMP environment

Educación

Bachelor’s degree in engineering

Herramientas

CMMS/EAM systems

P&IDs

Descripción del empleo

Sr. Equipment Process Engineer- Downstream

Location

Framingham, MA

About Job

The Sr. 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.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster.

About Sanofi

We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s 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. Together, we chase the miracles of science to improve people’s lives.

Main 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.

About You

Basic Qualifications

• Bachelor’s degree in mechanical, electrical, chemical, biomedical, or related engineering discipline, with at least 3 years of relevant engineering experience in manufacturing, facilities, utilities, laboratories, or complex process equipment in a regulated or high‑reliability environment.

• Candidates without a bachelor's degree must have at least 8 years of such experience.

• 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future‑focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks' gender‑neutral parental leave.
• 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.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.