Reliability Engineer

Sanofi Group; Munster; On-site; EUR 55,000 - 73,000; Full time

Job summary

Sanofi Waterford in Ireland seeks a Reliability Engineer to support the Rx program by driving reliability improvements and maintaining critical Fill & Finish equipment. You will implement predictive maintenance strategies, perform RCA/FMEA, monitor MTBF/MTTR, and ensure quality and GMP standards across maintenance activities.

The role focuses on collaboration with production, quality, and engineering teams to optimise maintenance plans, contribute to change controls, and advance continuous

Qualifications

• 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
• 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; data visualization skills are a plus
• Lean Six Sigma certification (Green Belt or higher) is advantageous

Responsibilities

• 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
• 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
• 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
• 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
• 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

Skills

Reliability engineering

RCA

FMEA

RCM

CMMS

GMP understanding

Data analysis

Lean Six Sigma

Project management

Communication

Education

Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, or related field)

Job description

Waterford

Full time

R

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.

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.

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !

The salary range for this position is :54 800,00 - 73 067

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

We are an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives.

We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting or via our movie We are Sanofi ( a career that makes a difference.

Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities.

This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.