Description:
An exciting opportunity has arisen for an experienced Reliability Engineer to join a leading global biopharmaceutical manufacturer. This role is ideal for an engineering professional with expertise in sterile manufacturing environments who is passionate about equipment reliability, continuous improvement, and supporting the production of life-changing medicines.
Working within the Site Reliability team, you will play a key role in supporting the delivery of a safe, reliable, and high-performing manufacturing facility. Initially, you will contribute during the project phase, supporting equipment installation, commissioning, and qualification before transitioning into operational support for commercial manufacturing and new product introductions.
This position offers the opportunity to work on state-of-the-art manufacturing facilities while collaborating with Engineering, Maintenance, Validation, Manufacturing, and Quality teams to drive reliability excellence.
Key Responsibilities
- Support the sterile drug product manufacturing facility from design through commissioning, qualification, and commercial operations.
- Develop and implement Reliability-Centred Maintenance (RCM) strategies to maximise equipment performance and plant reliability.
- Drive reliability excellence by implementing maintenance best practices aligned with site and global standards.
- Analyse equipment performance data to identify opportunities for reliability improvement, process optimisation, and sustainability initiatives.
- Lead Root Cause Analysis (RCA), FMEA, incident investigations, and troubleshooting activities for manufacturing equipment.
- Support equipment lifecycle management, including installation, commissioning, validation, and operational handover.
- Develop maintenance strategies, preventive maintenance programmes, and spare parts management plans.
- Support asset criticality assessments and optimise preventive and predictive maintenance programmes.
- Identify and implement condition-based and predictive maintenance technologies.
- Develop and monitor reliability KPIs, asset performance metrics, and Overall Equipment Effectiveness (OEE).
- Prepare and maintain engineering documentation, maintenance procedures, SOPs, and work instructions.
- Ensure compliance with GMP, engineering standards, health & safety regulations, and environmental requirements.
- Collaborate closely with Validation, Engineering, Operations, Maintenance, and Quality teams to support new equipment and new product introductions.
- Coach and support maintenance technicians, contractors, and vendors to ensure consistent engineering standards and best practices.
- Drive continuous improvement initiatives to enhance equipment reliability and operational performance.
About You
We're looking for an engineering professional who combines strong technical expertise with excellent problem-solving and stakeholder management skills.
You will ideally have:
- A degree in Mechanical, Electrical, Chemical, Process, Manufacturing, or related Engineering discipline.
- Several years' experience in reliability engineering, maintenance engineering, or equipment lifecycle management within a GMP-regulated manufacturing environment.
- Experience supporting sterile pharmaceutical, biologics, or highly regulated manufacturing operations.
- Strong knowledge of Reliability-Centred Maintenance (RCM), preventive and predictive maintenance strategies.
- Experience leading Root Cause Analysis (RCA), FMEA, and equipment failure investigations.
- Knowledge of equipment commissioning, qualification, validation, and operational handover.
- Experience with Computerised Maintenance Management Systems (CMMS), such as Maximo or SAP PM.
- Strong understanding of GMP, health & safety, engineering compliance, and regulatory requirements.
- Experience developing maintenance strategies, asset criticality assessments, and equipment reliability programmes.
- Excellent analytical, organisational, and project management skills.
- Strong communication skills with the ability to work effectively across multidisciplinary teams.