At a Glance
- Tasks: Ensure operational reliability of life-saving diagnostic equipment in a high-tech cleanroom.
- Company: Join Roche, a leader in innovative medical technology.
- Benefits: Competitive salary, career growth, and a vibrant work environment.
- Other info: Convenient location near Glasgow and Edinburgh with a supportive team culture.
- Why this job: Make a real difference in patient lives with cutting-edge technology.
- Qualifications: Engineering degree or equivalent experience in regulated manufacturing.
The predicted salary is between 30708 - 40000 £ per year.
About the Role
Are you ready to use your technical talents to make a direct impact on patient lives worldwide? Our Roche Motherwell Center of Excellence is one of Scotland’s premier, cutting-edge technology corridors. This facility boasts high-grade, automated cleanrooms and advanced bio-containment spaces that will genuinely challenge and elevate your technical expertise. We are seeking a dedicated and ambitious Maintenance Engineer to play a pivotal role in sustaining the production of our life-saving diagnostic sensors.
Operating within a high-precision, cleanroom environment, you will be responsible for ensuring the total operational reliability and safety of advanced manufacturing equipment while strictly maintaining its validated state. This role demands an agile professional who can perfectly balance proactive Planned Preventative Maintenance (PPM) with rapid, high-level troubleshooting to safeguard product efficacy and patient safety.
Key Responsibilities
- Preventative Maintenance & Reliability: Generate, execute, and manage comprehensive preventative maintenance programs (PMs) on advanced production equipment to maximize operational uptime and minimize unplanned downtime.
- Reactive Troubleshooting & RCA: Diagnose and resolve complex mechanical, electrical, and pneumatic system failures within a high-pressure, medical device production environment to eliminate supply gaps.
- Regulatory Compliance: 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.
- Equipment Validation: Support Quality and Engineering teams during the execution of IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols for new or modified machinery.
- Continuous Improvement: Identify and implement equipment optimization projects to systematically improve Overall Equipment Effectiveness (OEE) and manufacturing productivity.
- Documentation & Change Control: Lead or support updates to manufacturing documentation, including work instructions, risk assessments, and formal change control processes.
- Safety & Environment: Adhere strictly to all Safety, Health, and Environment (SHE) protocols, including Lockout/Tagout (LOTO) and strict cleanroom gowning/contamination control procedures.
- Inventory & Contractor Oversight: 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.
- Stakeholder Interaction & Teamwork: Work cross-functionally with key stakeholders across the business to drive operational excellence and ensure compliance.
Requirements & Key Skills
- Education: College or degree qualification in an appropriate engineering discipline, or significant equivalent relevant hands-on work experience.
- Industry Experience: Significant experience as a hands-on maintenance engineer within a highly regulated manufacturing environment, preferably within the medical device sector.
- Core Knowledge: Proven experience working comfortably within Good Manufacturing Practice (GMP) frameworks.
- Technical Expertise: 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.
- Problem-Solving: Strong analytical skills with a sense of urgency, balanced by a "quality-first" mindset to ensure patient safety and product efficacy.
- Digital & Technical Literacy: Competent in using Computerized Maintenance Management Systems (CMMS) and standard office software for technical reporting.
- Collaboration: 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.
Our Motherwell site is conveniently situated right off the M8, offering an easy, stress-free commute from both Glasgow and Edinburgh, bringing you a vibrant, fast-paced work environment where your maintenance skills directly impact life-saving diagnostic technology every day. Roche is an Equal Opportunity Employer.
Maintenance Engineer - Life-Saving Diagnostics (Mon-Fri) employer: Roche
At Roche, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Our Motherwell Center of Excellence not only provides state-of-the-art facilities but also prioritises employee growth through continuous training and development opportunities. Join us to make a meaningful impact on patient lives while enjoying a supportive environment that values your contributions and encourages professional advancement.
