Reliability Engineer

Sanofi; Waterford; Hybrid; EUR 55,000 - 73,000; Full time

Job summary

Sanofi Waterford site seeks a Reliability Engineer to lead reliability improvements for Fill and Finish equipment, optimise maintenance strategies and drive uptime and OEE through predictive approaches.

You will perform RCAs, FMEAs, and data analysis on MTBF/MTTR, collaborate with production, quality, and engineering, and ensure GMP-compliant documentation and change controls.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, or related field).
• Significant experience in reliability engineering, preferably in pharmaceutical or sterile manufacturing environments.
• Experience with Fill and Finish operations or aseptic processing is highly desirable.
• Strong knowledge of RCA, FMEA, and reliability methodologies.
• Proficiency in data analysis and CMMS.

Responsibilities

• Lead reliability improvement initiatives for Fill and Finish equipment to maximise uptime and OEE.
• Develop and implement predictive and preventive maintenance strategies.
• Conduct RCA and FMEA for equipment failures and chronic reliability issues.
• Monitor MTBF, MTTR, and availability metrics and report trends.
• Support GMP-compliant qualification, validation, and change controls.

Skills

RCA & FMEA

Lean Six Sigma

Data analysis

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

CMMS

Vibration analysis

Thermography

MS Excel

Data visualization tools

Job description

**Job Title:** Reliability Engineer* **Location:** Waterford, Ireland* **Job Type:** Permanent, Full-Time* **Shift Pattern**: Standard Days*About the job*As a Reliability Engineer, you'll be providing technical support to the Production Department on reliability improvement elements, as directed by the site's Reliability Excellence (Rx) Program. This includes the management of the production Predictive Maintenance system, building of Bill of Materials (BOMs) for Critical Fill Finish Equipment, progressing the build of critical spare parts, facilitating Failure Modes, Effects & Criticality Analysis (FMECA) events within Fill Finish, and generating/providing key data for Equipment Performance Reviews (EPRs) on critical production equipment.Ready to get started?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:****Equipment Reliability & Performance*** Lead reliability improvement initiatives for Fill and Finish equipment, including filling lines, lyophilizers, and ancillary equipment* Develop and implement predictive and preventive maintenance strategies to maximise equipment uptime and OEE* Conduct RCA and FMEA for equipment failures and chronic reliability issues* Monitor and analyse key performance metrics including MTBF, MTTR, and availability**Maintenance Strategy & Optimisation*** Review and optimise preventive maintenance schedules based on equipment criticality and failure history* Support the transition from reactive to predictive and condition-based maintenance approaches* Collaborate with maintenance teams to develop and update SOPs and work instructions**Technical Support & Problem Solving*** Provide technical expertise and troubleshooting support for Fill and Finish equipment issues* Work closely with production, quality, and engineering teams to resolve equipment-related constraints* Support qualification, validation, and change control activities, ensuring GMP compliance* Own and/or support Deviations, CAPAs, and Change Controls as required**Data Analysis & Continuous Improvement*** Collect, analyse, and report on reliability metrics and KPIs, identifying trends to drive proactive interventions* Lead or participate in continuous improvement projects using Lean and Six Sigma methodologies* Develop business cases for equipment upgrades or replacements based on reliability data**Compliance & Documentation*** Ensure all reliability activities comply with cGMP, FDA, EMA, and other applicable regulatory requirements* Maintain accurate documentation of reliability studies, analyses, and improvement initiatives* Support internal and external audits related to equipment reliability and maintenance*About you** Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, or related field)* Significant experience in reliability engineering, preferably in pharmaceutical or sterile manufacturing environments* Demonstrated experience with Fill and Finish operations or aseptic processing is highly desirable* Strong knowledge of reliability engineering principles, methodologies, and tools (RCA, FMEA, RCM)* Proficiency in data analysis, statistical methods, and CMMS (Computerized Maintenance Management Systems)* Understanding of GMP requirements and pharmaceutical manufacturing standards* Familiarity with predictive maintenance technologies (vibration analysis, thermography, oil analysis)* Excellent analytical and problem-solving skills with strong project management capabilities* Effective communication skills and ability to influence cross-functional teams* Proficiency in Microsoft Office Suite; experience with data visualization tools is a plus* Lean Six Sigma certification (Green Belt or higher) is advantageous*Why choose us?** Transform lives worldwide by delivering life-changing treatments anywhere, anytime.* Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.* Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.* Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.#LI-EURDiversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.The salary range for this position is :€54 800,00 - €73 067