Reliability Engineer TPM6096

Tandem Project Management Ltd.; Waterford; On-site; EUR 65,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. is sourcing a Reliability Engineer for a Waterford biopharma client. You will lead reliability improvements for Fill and Finish equipment in a sterile manufacturing environment, driving predictive maintenance and improving OEE.

Collaborate with Production, Maintenance, Quality and Engineering to resolve issues, optimise maintenance strategies and support GMP-compliant operations. A strong background in RCA/FMEA and data analysis is required.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Industrial or related engineering.
• 3–5 years reliability engineering experience, preferably in pharmaceutical or sterile manufacturing.
• Experience supporting Fill and Finish operations or aseptic processing is desirable.
• Strong knowledge of reliability principles, RCA, FMEA and RCMT.
• Proficiency in data analysis and statistical methods.
• Experience using CMMS.
• Understanding of GMP and pharmaceutical standards.
• Familiarity with predictive maintenance technologies (vibration, thermography, oil analysis).
• MS Office proficiency; data-visualisation tools beneficial.
• Lean Six Sigma Green Belt or higher is advantageous.

Responsibilities

• Lead reliability improvement initiatives for Fill and Finish equipment and related lines.
• Develop predictive and preventive maintenance strategies to maximise uptime and OEE.
• Conduct RCA and FMEA for failures and recurring issues.
• Monitor MTBF/MTTR and overall equipment availability.
• Review and optimise preventive maintenance schedules based on criticality and history.
• Support transition to predictive/condition-based maintenance approaches.
• Develop and update SOPs and work instructions with Maintenance teams.
• Identify opportunities for condition-based monitoring and tech deployment.
• Provide troubleshooting support for equipment issues.
• Collaborate with Production, Quality and Engineering to resolve constraints.
• Support qualification and validation activities for equipment changes.
• Participate in change-control processes per GMP requirements.
• Collect and report reliability metrics to drive proactive maintenance.

Skills

RCA

FMEA

RCM

Data analysis

CMMS

MS Office

Lean Six Sigma Green Belt

Vibration analysis

Thermography

Oil analysis

Predictive maintenance

OEE

Education

Bachelor's degree in Mechanical, Electrical, Industrial or related engineering

Tools

CMMS

Job description

Summary:

Our client, a leading biopharmaceutical company in Waterford, is seeking a Reliability Engineer to support Fill and Finish manufacturing operations within a sterile manufacturing environment. The successful candidate will lead equipment reliability improvements, reduce unplanned downtime and optimise asset performance across critical Fill and Finish equipment. This role will involve close collaboration with Production, Maintenance, Quality and Engineering teams to strengthen maintenance strategies, resolve equipment issues and support compliant, reliable manufacturing operations.

Responsibilities:

• Lead reliability improvement initiatives for Fill and Finish equipment, including filling lines, lyophilisers and ancillary equipment.
• Develop and implement predictive and preventive maintenance strategies to maximise equipment uptime and Overall Equipment Effectiveness (OEE).
• Conduct Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA) for equipment failures and recurring reliability issues.
• Monitor and analyse equipment performance measures, including Mean Time Between Failures (MTBF), Mean Time to Repair (MTTR) and equipment availability.
• Review and optimise preventive maintenance schedules based on equipment criticality, performance and failure history.
• Support the transition from reactive maintenance to predictive and condition-based maintenance approaches.
• Work with Maintenance teams to develop and update standard operating procedures and work instructions.
• Identify opportunities for condition-based monitoring and support the implementation of appropriate technologies.
• Provide technical expertise and troubleshooting support for Fill and Finish equipment issues.
• Work with Production, Quality and Engineering teams to resolve equipment-related production constraints.
• Support qualification and validation activities associated with equipment modifications and improvements.
• Participate in change-control processes and ensure equipment changes are implemented in accordance with GMP requirements.
• Collect, analyse and report reliability metrics and key performance indicators, identifying equipment-performance trends to support proactive maintenance interventions.
• Lead or support continuous improvement projects using Lean and Six Sigma methodologies and develop data-based business cases for equipment upgrades or replacements.
• Ensure reliability activities comply with cGMP and applicable regulatory requirements, including FDA and EMA expectations; maintain accurate documentation of reliability studies and improvement initiatives; and support internal and external audits relating to equipment reliability and maintenance.

Qualifications & Experience:

• Bachelor's degree in Mechanical, Electrical, Industrial or another relevant engineering discipline.
• A minimum of three to five years' reliability engineering experience, preferably within pharmaceutical or sterile manufacturing.
• Experience supporting Fill and Finish operations or aseptic processing is highly desirable.
• Strong knowledge of reliability engineering principles, methodologies and tools, including RCA, FMEA and Reliability-Centred Maintenance (RCM).
• Proficiency in data analysis and statistical methods.
• Experience using Computerised Maintenance Management Systems (CMMS).
• Understanding of GMP requirements and pharmaceutical manufacturing standards.
• Familiarity with predictive maintenance technologies such as vibration analysis, thermography and oil analysis.
• Proficiency in Microsoft Office; experience with data-visualisation tools is advantageous.
• Lean Six Sigma certification at Green Belt level or higher is advantageous.