About this role
Role Overview
- Generate, execute, and manage comprehensive preventative maintenance programs (PMs) on advanced production equipment to maximize operational uptime and minimize unplanned downtime.
- Diagnose and resolve complex mechanical, electrical, and pneumatic system failures within a high-pressure, medical device production environment to eliminate supply gaps.
- Maintain meticulous records and data integrity in strict accordance with ISO 13485, FDA 21 CFR Part 820, and GxP standards to ensure equipment remains in its validated state.
- Support Quality and Engineering teams during the execution of IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols for new or modified machinery.
- Identify and implement equipment optimization projects to systematically improve Overall Equipment Effectiveness (OEE) and manufacturing productivity.
- Lead or support updates to manufacturing documentation, including work instructions, risk assessments, and formal change control processes.
- Adhere strictly to all Safety, Health, and Environment (SHE) protocols, including Lockout/Tagout (LOTO) and strict cleanroom gowning/contamination control procedures.
- Proactively manage inventory levels for critical components to ensure rapid response times. Coordinate third-party contractor site visits, performing rigorous reviews of RAMS (Risk Assessments and Method Statements) and supervising works.
- In this role, serve as a vital technical linchpin working cross-functionally with key stakeholders across the business to drive operational excellence and ensure compliance.
Requirements
- College or degree qualification in an appropriate engineering discipline, or significant equivalent relevant hands-on work experience.
- Significant experience as a hands-on maintenance engineer within a highly regulated manufacturing environment, preferably within the medical device sector.
- Proven experience working comfortably within Good Manufacturing Practice (GMP) frameworks.
- Strong proficiency in diagnosing mechanical and electrical systems.
- Specific knowledge of rotary converting or reel-to-reel printing (flexographic/rotary screen) is a significant advantage.
- Strong analytical skills with a sense of urgency, balanced by a 'quality-first' mindset to ensure patient safety and product efficacy.
- Competent in using Computerized Maintenance Management Systems (CMMS) and standard office software for technical reporting.
- Skilled in authoring clear technical documentation and maintenance work instructions.
- A proactive team player who takes full accountability for seeking solutions and supporting the continuous development of colleagues.
- Must hold a full, clean UK driving licence.
- Ready to work in shifts; Monday to Friday.
Benefits
- Professional development opportunities