Reliability Engineer – Predictive Maintenance & FMEA

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

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