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To conduct, coordinate and manage equipment related maintenance and improvement activity in order that equipment availability, reliability and capability is continuously improved. Lead equipment related capital investment in association with the Compounding facilities and equipment budget. Ensure all equipment is calibrated and maintained in compliance with the requirements of cGMP, FDA, ISO13485 and EHS Legislation.
Job Responsibility:
Demonstrate a Safety first approach to every single aspect of the role
Lead trouble shooting, fault finding & resolution to root cause of compounding related plant and equipment
Lead shutdown planning and execution, inclusive of shutdown and start up activities
To implement the engineering improvement plan for the Compounding Unit
Heavy focus on reliability of plant and equipment, working relentlessly to ensure that plant availability & OEE metrics are continuously improved
To deliver best in class equipment availability and reliability through reactive, preventative and predictive maintence techniques
To plan and direct the installation, testing, operation, maintenance and repair of all facilities and equipment within the Compounding Unit
To develop and implement Preventative Maintenance procedures & schedules that assures equipment availability and reliability and product quality in line with the Compounding Engineering Strategy and Baxter Perfect Equipment requirements
Active member of the Perfect Equipment Steering Committee
Provide a standardised Perfect Equipment system across the Compounding Unit in collaboration with local operational staff and the UK Engineering Manager
To direct and co-ordinate the engineering activities associated with all Compounding plant and equipment, managing contractors, service providors, installation engineers etc.
To coordinate and direct engineering projects associated to the Compounding Unit such that they are completed on time and within budget
To perform administrative functions, review and write reports, and make decisions on the purchase of parts, equipment and services
Team member and Project Manager for the delivery of the Site Project portfolio
Identification and management of critical spares inventory for the Unit and liaise with other Compounding Units for parts sharing initiatives
Management of external contractors in line with EHS safe systems of work
Management of external resources from OEM’s, service providors, calibration providers, installations engineers and any other external resouse as necessitated within the Coumpounding Engineering Strategy
Review of contratcors day sheets to enable accuracy of information, problem resolution and cost effectiveness
Requirements:
Good level of experience of maintaining electrical and mechanical plant and equipment
A Craft Apprenticeship (& HNC preferred) in Electrical, Mechanical or Instrumentation Engineering
At least 5 years’ experience as a hands on multi-skilled engineer maintaining electrical, control, mechanical and pneumatic related plant and equipment
Experience of installation of new plant and equipment
Excellent interpersonal and communication skills
Responsive and flexible attitude to supporting internal and external customer requirements
Experience of working as a support function with a high focus on reliability
Rapid appreciation of issues, sound judgement and problem solving skills
Ability to work under pressure and to tight deadlines within a dedicated team
Knowledge and experience of clean room operations and associated equipment
Practical Problem Solving
GMP
Project Management
Risk Assessment
Failure Mode Effect Analysis
Negotiation skills
Budget Management
Minimum of 3 years Experience of effective equipment maintenance and maintenance scheduling within the Pharmaceutical / Medical Device industry