Role Summary
- The Multi-skilled Maintenance Engineer will be responsible for maintaining specialist pharmaceutical equipment and facility installations to support our manufacturing and QC operations.
- They will be primarily responsible for equipment breakdown repairs & ongoing maintenance work of manufacturing equipment and associated utility systems.
- They will plan and complete a range of reactive & planned maintenance works associated within the GMP facility & lab as well as order and maintain critical spares.
- The role will be shift-based working full-time on a rolling shift pattern of 2 on-2 off, 3 on-2 off, 2 on-3 off. This will rotate across earlies and lates every 14 days. The early shift will start from 0600 AM to 1600 PM; late shift will be from 1100 AM to 2300 PM.
Key Responsibilities
- Responding to & diagnosing faults and repair of equipment breakdowns.
- Repairing & improving other equipment issues.
- Ensuring equipment is handed back to production in 100% safe condition.
- Conducting risk assessment prior to any maintenance work.
- Completing breakdown & repair reports.
- Planning and undertaking scheduled maintenance.
- Creating maintenance procedures (Including writing SOPs).
- Managing contractors and their activities.
- Providing support to Facilities, Validation and Capital Project Engineering as required.
- Managing stocks of critical engineering spares and equipment.
- Maintaining an engineering workshop.
- Providing operator training as necessary.
- Using manuals and failure history to develop preventative tasks.
- Providing SME support to other business functions.
- Deputising in other roles as required.
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
- 3 years of working within a clean room and regulated environment. (P)
- Working in a Pharmaceutical or other heavily regulated industry. (E)
- HVAC, compressed gases, and integrated control systems knowledge. (P)
- Operating within the requirements of a Quality Management system. (E)
- Project management experience. (P)
- Equipment validation lifecycle knowledge. (P)
- Control system (PLC) experience. (E)
- CMMS experience (E)
- Experience of managing and performing planned preventive maintenance. (E)
- Experience in GMP standard quality management systems (i.e. CAPAs, CCs & Deviations) (E)
Qualifications
- Bachelor of Science – Relevant engineering degree or HNC/D with relevant experience.
Skills/Specialist knowledge
- Working with small/medium scale manufacturing and analytical equipment.
- Pharmaceutical utility systems and controls.
- BMS and EMS.
- Clean room operations.
- Computer literate – Microsoft Office suite.
- Knowledge and expertise in small scale pharmaceutical manufacturing equipment. (P)
- Knowledge of current standards, procedures, and controls for GMP cleanroom facilities and equipment. (P)
- Knowledge and expertise in utility systems from HVAC to medical gases etc. (E)
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Contact Detail:
Autolus Limted Recruiting Team