Senior Specialist - Sterile Drug Product Reliability Engineer
Overview
An experienced Engineering professional is required to join the Site Reliability team. Reporting to the Senior Manager, Site Reliability SME, the Senior Specialist, Sterile Drug Product Reliability Engineer will support the Sterile Drug Product (SDP) maintenance team in delivering a safe, reliable, and compliant manufacturing facility to ensure continuity of pharmaceutical production.
The successful candidate will initially support the facility during the project phase, assisting with equipment installation and commissioning from design through to final handover. The role will transition into operational support, contributing to facility start-up, commercial manufacturing, GMP readiness, and new product introductions.
The role also focuses on ensuring compliance with engineering best practices, applicable regulations, and industry standards while supporting maintenance and reliability objectives aligned with wider engineering and operational goals.
Key Responsibilities
- Support the sterile drug product manufacturing facility from design through commissioning and into routine operations.
- Develop and implement a reliability-centred maintenance (RCM) strategy to support safe, efficient, and reliable manufacturing operations.
- Design and implement a consistent reliability excellence model aligned with the site's operating model.
- Use engineering and business data analytics to identify opportunities for improving asset reliability, process optimisation, and environmental sustainability.
- Lead reliability engineering activities including:
- Root Cause Analysis (RCA)
- Failure Mode and Effects Analysis (FMEA)
- Incident investigations
- Equipment troubleshooting
- Manage complex engineering problems, equipment lifecycle activities, reliability improvement projects, and continuous improvement initiatives.
- Promote a safe working environment through compliance with environmental, health and safety requirements.
Project Phase Responsibilities
Provide reliability engineering support during project delivery, including:
- Development of reliability-centred maintenance programmes.
- Spare parts and inventory strategy.
- Preventive and predictive maintenance planning.
- Statutory inspection programme development.
- Application of lessons learned from comparable pharmaceutical manufacturing facilities.
- Development of maintenance KPIs, asset reliability metrics, and Overall Equipment Effectiveness (OEE) targets.
- Asset criticality assessments.
- Preventive maintenance and work order development.
- Identification and implementation of Predictive Maintenance (PdM) and Condition-Based Maintenance (CBM) opportunities.
- Support for statutory compliance, machinery safety, and process safety management programmes.
Operational Phase Responsibilities
Provide ongoing reliability engineering support for manufacturing operations by:
- Maintaining and improving reliability-centred maintenance programmes in line with company procedures and industry standards.
- Supporting maintenance management system governance and engineering change processes.
- Working collaboratively with Operations and Maintenance teams to improve equipment reliability.
- Developing engineering documentation including:
- Standard Operating Procedures (SOPs)
- Work Instructions
- Maintenance documentation
- Supporting the implementation and expansion of condition-based maintenance technologies.
- Reviewing inspection, testing, and preventive maintenance programmes to optimise maintenance effectiveness.
- Supporting new equipment introduction, commissioning, validation, and lifecycle management.
- Developing the technical capability of maintenance technicians, contractors, and equipment vendors.
Additional Responsibilities
- Support engineering SMEs, project teams, and validation activities.
- Monitor, analyse, and report reliability KPIs and asset performance metrics.
- Contribute to continuous improvement initiatives that enhance equipment reliability, operational efficiency, and regulatory compliance.
