We are currently seeking a Reliability Engineer for an initial 12-month contract supporting Fill & Finish manufacturing operations within a highly regulated pharmaceutical environment. The successful candidate will play a key role in improving equipment reliability, reducing unplanned downtime, and driving asset performance across critical manufacturing systems. This position offers the opportunity to work closely with Maintenance, Production, Quality and Engineering teams to support operational excellence and continuous improvement initiatives.
Responsibilities:
- Lead reliability improvement activities for Fill & Finish manufacturing equipment, including filling lines, lyophilizers and associated process equipment.
- Develop and optimise preventive and predictive maintenance strategies to maximise equipment uptime and overall equipment effectiveness (OEE).
- Conduct Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA) and reliability assessments to identify and eliminate recurring equipment issues.
- Monitor equipment performance using key reliability metrics such as MTBF, MTTR and asset availability.
- Review maintenance plans and identify opportunities to improve maintenance effectiveness and equipment reliability.
- Support the transition from reactive maintenance practices to predictive and condition-based maintenance strategies.
- Provide technical troubleshooting support for equipment-related issues impacting manufacturing operations.
- Collaborate with Production, Maintenance, Quality and Engineering teams to resolve reliability concerns and improve equipment performance.
- Support equipment modifications, upgrades, qualification activities and change control processes.
- Analyse reliability data and identify trends to drive continuous improvement initiatives.
- Participate in Lean and Six Sigma projects focused on improving asset performance and operational efficiency.
- Ensure all activities comply with GMP, FDA and regulatory requirements.
- Maintain accurate documentation, reliability reports, investigations and maintenance records.
- Support internal and external audits relating to equipment reliability and maintenance programs.
Requirements:
- Bachelor's Degree in Mechanical, Electrical, Industrial or related Engineering discipline.
- Minimum 3-5 years' experience in Reliability Engineering, Maintenance Engineering or Asset Management within a regulated manufacturing environment.
- Previous pharmaceutical, biotech, medical device or sterile manufacturing experience is highly desirable.
- Experience supporting Fill & Finish, aseptic processing or similar manufacturing operations would be an advantage.
- Strong knowledge of reliability engineering methodologies including RCA, FMEA and Reliability-Centred Maintenance (RCM).
- Experience developing and optimising preventive and predictive maintenance programs.
- Familiarity with reliability KPIs including MTBF, MTTR and OEE.
- Experience using CMMS systems and analysing maintenance and equipment performance data.
- Understanding of GMP requirements and pharmaceutical manufacturing standards.
- Knowledge of predictive maintenance technologies such as vibration analysis, thermography or condition monitoring techniques is desirable.
- Strong analytical, problem-solving and troubleshooting skills.
- Excellent communication skills with the ability to collaborate across multidisciplinary teams.
- Lean Six Sigma certification (Green Belt or higher) would be advantageous.
- Proficiency in Microsoft Office applications; experience with data visualisation tools is beneficial.