Reliability & Methods Engineer

Sanofi • Framingham, MA

1d • $100,500 - $145,167 • Onsite

About The Position

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

The position is part of Sanofi’s Site Maintenance & Reliability organization, which 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 site operations while enabling manufacturing and project delivery and meeting regulatory, quality, environmental, health, and safety requirements.

The engineer analyzes asset and maintenance data; assesses equipment criticality and risk; leads root-cause investigations; optimizes maintenance strategies; evaluates work orders and spare-parts risk; and leads reliability improvements and lifecycle planning. The role also provides reliability requirements for projects and modifications, supports commissioning, qualification, and operational readiness, develops standards and analytical methods, coaches colleagues, and maintains inspection-ready technical documentation. 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. It may require gowning and access to manufacturing areas, presence in operating and maintenance areas, participation in shutdowns and start-ups, and on-call support in accordance with site scheduling and escalation practices.

Requirements

• Bachelor’s degree in mechanical, electrical, chemical, biomedical, or a 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.
• 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.

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 condition-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 based on equipment criticality, failure modes, technical feasibility, data quality, and cost; define routes, frequencies, alarm limits, response workflows, training needs, and performance measures.
• Recommend approved additions, revisions, consolidations, conversions, or retirements of maintenance tasks using risk, failure history, condition data, and field feedback.
• Review corrective, preventive, predictive, and emergency work orders to identify repeat failures, maintenance-induced events, planning gaps, parts usage, and job-plan improvement opportunities.
• Monitor critical spares, long-lead components, repairable assets, shelf-life exposure, obsolete inventory, and stockout risk; recommend stocking levels and 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 for systemic or longer-term improvements; 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, supplier performance, 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, system 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 to confirm reliability, maintainability, accessibility, redundancy, control strategy, safe-work, and lifecycle requirements.
• Develop and maintain reliability standards, tools, templates, and analytical methods.
• Coach engineers, planners, mechanics, technicians, and system owners in reliability principles, investigation methods, and data-driven decision-making.
• Maintain accurate, traceable, current, and inspection-ready technical documentation.
• Support planned shutdowns, utility outages, start-ups, system restoration, emergency conditions, and manufacturing escalations.
• Select appropriate reliability methods, data sources, analytical tools, and assumptions; determine engineering risk ratings and recommend actions through applicable governance processes.
• Prioritize bad actors and systemic reliability improvements based on safety, compliance, frequency, cost, and business impact; escalate significant risks, repeat failures, overdue actions, and material cost, compliance, schedule, or manufacturing exposure.
• Complete assigned analyses, investigations, CAPAs, change requests, work-order reviews, inventory-risk assessments, and technical documentation accurately and on time.

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; details are available through the company benefits information.

What This Job Offers

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