Reliability & Methods Engineer

Sanofi • Framingham, MA

1d • $100,500 - $145,167 • Onsite

About The Position

The Reliability Engineer improves the reliability, maintainability, safety, and lifecycle performance of cGMP and non-cGMP manufacturing, utility, facility, and process systems. Using asset-performance data, risk assessments, failure investigations, predictive technologies, and maintenance history, the role identifies systemic issues and implements sustainable improvements. The engineer leads reliability investigations, preventive and predictive maintenance optimization, CAPAs, change controls, lifecycle planning, and reliability-centered improvements to single-use technology systems.

The role is part of Site Maintenance & Reliability, an organization that provides corrective and preventive maintenance, reliability engineering, calibration support, and technical services for site buildings, equipment, utilities, and manufacturing systems. The organization supports reliable, efficient, and sustained asset operation while enabling manufacturing, project delivery, business objectives, and compliance with regulatory, quality, environmental, health, and safety requirements.

Responsibilities include analyzing asset-performance and maintenance data; assessing equipment criticality and risk; leading failure investigations and corrective actions; optimizing maintenance strategies; reviewing work orders and spare-parts risks; leading reliability improvements and lifecycle planning; supporting single-use technology improvements, projects, commissioning, and operational readiness; and maintaining reliability standards and inspection-ready technical documentation. The position works cross-functionally with site maintenance, engineering, manufacturing, quality, validation, metrology, HSE, automation, procurement, stores, and suppliers. Work is performed in accordance with cGMP, data-integrity requirements, Quality Systems, site procedures, HSE requirements, OSHA expectations, engineering standards, and approved change-control processes.

The role is based in Framingham, Massachusetts. Work may involve gowning and entering manufacturing, operating, and maintenance areas; supporting troubleshooting, inspections, and vendor activities; and participating in planned shutdowns, utility outages, start-ups, and restoration activities. On-call support may be required in accordance with site requirements.

Requirements

• Bachelor's degree in mechanical, electrical, chemical, biomedical, or related engineering discipline and 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.
• Applied experience with reliability methods such as FMEA/FMECA, RCM, asset criticality, MTBF/MTTR, lifecycle costing, Pareto analysis, root-cause failure analysis, and maintenance-strategy optimization.
• Experience working in a regulated environment, including cGMP and applicable OSHA and environmental requirements.
• Experience analyzing CMMS/EAM, work-order, downtime, deviation, condition-monitoring, or inventory data.
• Experience leading equipment investigations, continuous-improvement initiatives, CAPAs, or change controls.
• Working knowledge of BMS, EMS, DCS, CMMS/EAM, data-visualization tools, and Microsoft Office applications.
• Strong technical writing, communication, facilitation, coaching, and cross-functional leadership skills.
• Ability to gown and access manufacturing areas and enter operating and maintenance areas for troubleshooting, equipment inspections, and vendor activities.
• Participation in planned site shutdowns, utility outages, system start-ups, and restoration activities; on-call support may be required in accordance with site requirements.

Nice To Haves

• Experience in pharmaceutical or biotechnology manufacturing.
• Knowledge of manufacturing equipment, utility systems, process equipment, and single-use technologies.
• Experience implementing predictive-maintenance or condition-monitoring programs.
• Experience with commissioning, qualification, validation, and equipment lifecycle management.
• Familiarity with SAP, Maximo, Infor EAM, or comparable CMMS/EAM platforms.
• Experience with Lean, Six Sigma, statistical analysis, continuous improvement, or data visualization.
• CMRP, CRL, Lean/Six Sigma, project-management, Professional Engineer, or equivalent professional certification.

Responsibilities

• Analyze CMMS/EAM, downtime, deviation, work-order, maintenance-cost, condition-monitoring, spare-parts, and equipment-history data.
• Develop reliability dashboards, bad-actor lists, Pareto analyses, repeat-failure trends, and MTBF/MTTR reporting.
• Assess equipment criticality and risk using FMEA/FMECA, reliability-centered maintenance, safety, compliance, product impact, redundancy, obsolescence, and business-continuity considerations.
• Recommend risk mitigation, monitoring, acceptance, escalation, or asset replacement strategies.
• Lead root-cause investigations for recurring, complex, high-impact, or poorly understood equipment failures.
• Evaluate failed components, alarms, operating conditions, maintenance history, design information, and human factors during investigations.
• Investigate emerging reliability concerns such as degrading performance, repeat work orders, nuisance alarms, abnormal monitoring results, and increasing parts consumption.
• Develop sustainable corrective actions and verify their effectiveness.
• Develop and optimize preventive, predictive, and condition-based maintenance strategies.
• Select monitoring technologies and define routes, frequencies, alarm limits, response workflows, training needs, and program performance measures.
• Use risk, failure history, condition data, and field feedback to update maintenance tasks through approved governance processes.
• Review work orders to identify repeat failures, maintenance-induced events, planning gaps, parts usage, and opportunities to improve job plans.
• Monitor critical spares, long-lead components, repairable assets, shelf-life exposure, obsolete inventory, and stockout risk; recommend inventory strategies.
• Lead bad-actor elimination, equipment upgrades, system modifications, and replacement recommendations.
• Develop technical scopes, lifecycle cost evaluations, business cases, implementation plans, and effectiveness measures.
• Lead reliability-related CAPAs and change requests and support reliability-related capital projects and system modifications.
• Lead reliability-centered improvements to single-use technology assemblies and systems, evaluating failure modes, components, interfaces, operating limits, installation practices, leak risk, suppliers, usability, standardization, and maintainability.
• Coordinate approved single-use technology changes with Manufacturing, Process Engineering, Quality, Validation, Procurement, and suppliers.
• Provide reliability requirements for new equipment, modifications, capital projects, commissioning, qualification, and operational readiness.
• Define equipment criticality, maintenance strategies, predictive-monitoring requirements, spare-parts needs, acceptance criteria, documentation, and training requirements.
• Participate in design reviews addressing reliability, maintainability, accessibility, redundancy, control strategy, safe work, and lifecycle requirements.
• Develop and maintain reliability standards, tools, templates, and analytical methods; coach colleagues and system owners in reliability principles and data-driven decision-making.
• Maintain accurate, traceable, current, inspection-ready technical documentation and perform work in accordance with applicable quality, safety, regulatory, and change-control requirements.
• Support planned shutdowns, utility outages, start-ups, system restoration, emergency conditions, and manufacturing escalations.
• Select reliability methods, data sources, analytical tools, and assumptions; determine engineering risk ratings and recommend actions through applicable governance.
• Prioritize systemic reliability improvements, accountably complete assigned analyses and documentation, and escalate significant risks, repeat failures, overdue actions, and material exposure.
• Support gowning and access to manufacturing areas, troubleshooting and inspections in operating and maintenance areas, and vendor activities; participate in planned site outages and restoration activities.

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; further information is available through the company benefits information.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level