Reliability & Methods Engineer

Sanofi; Pocono Township (PA); On-site; USD 86,000 - 124,000; Full time

Benefits offered by this job

14 weeks gender-neutral parental leave

Health and wellbeing benefits

Job summary

Sanofi is seeking a Reliability & Methods Engineer to drive the reliability, availability, and compliance of production equipment across its Swiftwater site. You will lead RCM, FMEA, and RCA activities, optimize preventive/predictive maintenance in SAP PM/EAM, and work with cross-functional teams to reduce downtime and improve OEE.

You will analyze equipment performance data, manage spare parts strategy, and support capital projects while ensuring GMP compliance and change control adherence.

Qualifications

• Bachelor’s degree in engineering or related field.
• 3+ years in engineering and maintenance of GMP production equipment.
• Experience with RCA, RCM, FMEA, and OEE.
• Experience with SAP PM/EAM and data analysis.
• Knowledge of pharma regulations (cGMP, FDA, ISO).
• Strong analytical and cross-functional collaboration skills.

Responsibilities

• Develop and execute reliability strategies (RCM, FMEA, criticality).
• Lead RCA for equipment failures and manage CAPA actions.
• Optimize preventive/predictive maintenance and PM tasks in SAP.
• Analyze downtime, stops, changeovers to quantify impact.
• Collaborate with Maintenance, Manufacturing, Quality, Validation, Engineering.
• Manage OEM/vendor relations, spare parts strategy, and obsolescence.
• Prepare technical docs and support capital projects and changes.
• Interface with site leadership on budget, cost tracking, and spend.

Skills

Reliability engineering

Root cause analysis (RCA)

FMEA

OEE

Data analysis

GMP familiarity

Cross-functional collaboration

Education

Bachelor’s degree

CMRP / CRE / Six Sigma (certifications)

Tools

SAP PM/EAM

Power BI

CMMS/EAM

Job description

Job Title : Reliability & Methods Engineer

• Location: Swiftwater, PA

About the Job

The Reliability Engineer is a critical technical role under the Reliability & Engineering Manager pillar, responsible for ensuring the reliability, availability, and compliance of equipment across our manufacturing operations. You will serve as a technical expert in reliability engineering, driving data-driven maintenance strategies, root cause investigations, and continuous improvement initiatives that enable our teams to deliver high-quality medicines to patients without interruption.

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 lives.

Main Responsibilities

In this role, you will take ownership of the reliability performance of production equipment and systems across the site. You will develop and execute reliability-centered maintenance (RCM) strategies, optimize preventive and predictive maintenance programs, and lead failure analysis efforts (RCA, FMEA) to reduce unplanned downtime, minimize product loss, and improve overall equipment effectiveness (OEE).

You will use SAP (PM/EAM) data, equipment performance metrics, and maintenance history to identify trends, quantify losses, and prioritize improvement opportunities. You will partner closely with Manufacturing, Maintenance, Quality, Validation, and Engineering to implement sustainable fixes, support equipment changeovers and modifications, and ensure that all changes are executed in compliance with GMP and change control requirements.

You will also manage OEM and vendor technical relationships, support spare parts strategy and criticality assessments, and contribute to capital projects and equipment upgrades. As a key contributor to Sanofi’s operational excellence and digital transformation initiatives, you will help ensure our manufacturing operations are robust, compliant, and ready for the future.

Reliability Engineer

Position Overview: Reliability Engineer responsible for the performance, availability, and lifecycle management of production equipment and systems, ensuring compliance with GMP and quality standards.

Key Responsibilities:

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

About You

Basic Qualifications

• Bachelor’s degree.
• 3+ years of experience in engineering and maintenance of production equipment in a GMP-regulated environment.
• Proven experience with reliability engineering methodologies (RCA, RCM, FMEA, failure analysis, OEE).
• Experience with SAP (PM/EAM) and maintenance data analysis.
• In-depth knowledge of engineering and maintenance principles in pharmaceutical manufacturing processes, including technical knowledge of 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, including cGMP, FDA, EU Annex 1, and ISO standards.
• Excellent analytical and problem-solving skills to address complex technical issues.
• Excellence in cross-functional collaboration, leadership, and technical communication.
• Financial acumen related to maintenance budgeting, cost tracking, and procurement.

Desired Skills:

• Hands-on experience with Inova/ Optima filling equipment (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 (vibration, thermography, data analytics).
• Experience with CMMS/EAM, data visualization tools (Power BI, 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.
• Preferred Certifications: CMRP, CRE, Six Sigma Green/Black Belt, or equivalent.

Core Competencies:

• Technical expertise in production equipment and reliability engineering
• Quality- and compliance-focused mindset
• Analytical and structured problem solving
• Process improvement orientation
• Strong communication and influencing skills
• Training and knowledge-sharing capabilities
• Change management proficiency

This position plays a crucial role in ensuring the reliability and compliance of our manufacturing operations, directly supporting Sanofi’s commitment to supply continuity and operational excellence for patients worldwide.

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 andwellness 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 Inc. 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.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

US and Puerto Rico Residents Only

Sanofi Inc. 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.

The salary range for this position is:

$85,500.00 - $123,500.00

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.