Reliability Engineer

Sanofi

Waterford

Hybrid

EUR 65,000 - 90,000

Full time

2 days ago

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Job summary

Sanofi in Waterford, Ireland, seeks a Reliability Engineer to drive reliability improvements for Fill and Finish systems and manage predictive maintenance data. You’ll lead RCA/FMEA activities, optimise maintenance strategies, and work across production, quality, and engineering to comply with GMP.

You will analyse KPIs, develop business cases for upgrades, and support deviations, CAPAs, and change controls while applying Lean Six Sigma methodologies in a compliant manufacturing setting.

Qualifications

Bachelor's degree in Engineering or related field.
Significant reliability engineering experience in pharma or sterile manufacturing.

Responsibilities

Lead reliability improvement initiatives for Fill and Finish equipment.
Develop predictive and preventive maintenance strategies to maximise uptime and OEE.
Conduct RCA and FMEA for equipment failures and chronic issues.
Monitor MTBF, MTTR, and availability to drive improvements.
Review preventive maintenance schedules based on criticality and history.
Support transition to predictive/condition-based maintenance.
Collaborate with maintenance to update SOPs and work instructions.
Provide troubleshooting support and resolve equipment constraints.
Support qualification, validation, and change control activities (GMP).
Own or support deviations, CAPAs, and change controls.

Skills

RCA

FMEA

RCM

Data analysis

Vibration analysis

Thermography

Oil analysis

Lean Six Sigma

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

CMMS

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