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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 & on-going 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 role working full-time basis 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 0600AM to 1600PM; late shift will be from 1100AM to 2300PM.
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.
• Provide 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 gasses etc. (E)
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