Reliability & Methods Engineer

Sanofi • Swiftwater, PA

1d • Onsite

About The Position

The Reliability & Methods Engineer is responsible for the reliability, availability, compliance, and lifecycle management of production equipment and systems across Sanofi’s manufacturing site in Swiftwater, Pennsylvania. The role develops and executes reliability-centered maintenance strategies, improves preventive and predictive maintenance programs, and leads failure analyses to reduce unplanned downtime, product loss, and equipment effectiveness losses. It uses SAP PM/EAM data, equipment performance metrics, and maintenance history to identify trends and prioritize improvements.

The engineer works cross-functionally with Manufacturing, Maintenance, Quality, Validation, and Engineering to implement sustainable fixes and support startups, changeovers, modifications, and qualification activities in compliance with GMP and change-control requirements. The role also manages OEM and vendor technical relationships, establishes critical-spare-parts strategies, contributes to capital projects and equipment upgrades, and supports budgeting and cost tracking. The position contributes to operational excellence and digital transformation while helping maintain robust, compliant manufacturing operations and continuity of supply.

Requirements

• Bachelor’s degree.
• At least 3 years of experience in engineering and maintenance of production equipment in a GMP-regulated environment.
• Experience with reliability engineering methods, including RCA, RCM, FMEA, failure analysis, and OEE.
• Experience with SAP PM/EAM and maintenance data analysis.
• In-depth knowledge of engineering and maintenance principles in pharmaceutical manufacturing, including process equipment and automated mechanical systems.
• Ability to read, create, and interpret mechanical drawings, P&IDs, electrical schematics, technical documentation, and PLC/HMI documentation.
• Familiarity with pharmaceutical regulations and standards, including cGMP, FDA requirements, EU Annex 1, and ISO standards.
• Strong analytical and problem-solving skills for complex technical issues.
• Cross-functional collaboration, leadership, and technical communication skills.
• Financial acumen related to maintenance budgeting, cost tracking, and procurement.

Nice To Haves

• Hands-on experience with Inova/Optima filling equipment, including operation, maintenance, troubleshooting, or engineering support.
• Familiarity with aseptic processing equipment, isolator/RABS technology, and aseptic intervention principles.
• Knowledge of predictive maintenance and condition-monitoring technologies, such as vibration, thermography, and data analytics.
• Experience with CMMS/EAM systems, data visualization tools such as Power BI or Spotfire, and Lean/Six Sigma methodologies.
• Understanding of spare-parts management and procurement workflows.
• Project management experience, including capital project execution.
• Experience with SAP S/4HANA and Fiori applications.
• CMRP, CRE, Six Sigma Green Belt, Six Sigma Black Belt, or equivalent certification.
• Training and knowledge-sharing capabilities.
• Change management proficiency.

Responsibilities

• Develop, implement, and improve reliability strategies, including RCM, FMEA, criticality assessments, and equipment strategy optimization.
• Lead root cause analysis of equipment failures, deviations, and chronic losses, and define and track corrective and preventive actions.
• Optimize preventive and predictive maintenance programs and SAP PM task lists to improve MTBF, MTTR, and OEE.
• Analyze downtime, minor stops, changeovers, rejects, and other equipment performance data to identify improvement opportunities and quantify business impact.
• Partner with Maintenance, Manufacturing, Quality, and Validation teams on startups, changeovers, equipment modifications, and qualification activities.
• Manage OEM and vendor technical relationships, including service support, upgrades, obsolescence planning, and troubleshooting.
• Define and manage critical spare-parts strategy, including min/max levels, criticality, and obsolescence risk.
• Author and review SOPs, work instructions, change controls, deviations, and engineering reports.
• Support capital projects, equipment upgrades, and technology transfers.
• Work with site leadership, Finance, and Procurement on maintenance budgets, cost tracking, and spend justification.
• Ensure equipment and system changes comply with GMP, quality standards, and change-control requirements.

Benefits

• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Rewards package recognizing employee contributions.
• Opportunities for career growth and development, including promotions or lateral moves and international opportunities.
• Employees may be eligible to participate in company employee benefit programs.

What This Job Offers

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