This is a significant role within the Utilities & Facilities organization and requires a person to provide technical expertise and drive the development and reliability improvement programs of existing clean utilities and water systems.
The successful candidate for this role will have proven experience in applying trouble shooting and diagnostics techniques on the above systems, generating corrective and improvement plans, implementing these plans and ensuring that the stated objectives are achieved.
These plans may include some of the following elements: capacity threshold analysis, reliability/ mean time to failure analysis, equipment efficiency, downtime reduction, preventative maintenance, condition monitoring, change control and training etc.
- Operational start-up and system owner of high-purity utility systems (Purified Water, Pure Steam, Sterile Process Air, HVAC, LAF enclosures, etc.)
- Operational start-up and system owner for other facilities utilities including; high pressure steam systems, nitrogen generation systems, vacuum conveying systems, HVAC, HEPA and clean room services, DI water, compressed air, solvent storage and distribution systems, chilled water systems, CHP systems and software control systems including BMS, QBMS and CMMS.
- Review and execution of qualification protocols for utilities and process systems
- Trouble-shooting of plant and equipment including reviewing and analysing trends and alarm histories
- Preparation of operational procedures and preventative maintenance routines for new GMP-grade equipment and systems
- Training of plant personnel in SOPs and PMs
- Provision of technical support and direction to the operations and maintenance personnel
- Ensure that GMP and quality standards and procedures are maintained
- Ensure that Environmental and Health and Safety standards are maintained
Education / Experience
- Degree in Marine/Mechanical/Process/Chemical Engineering
- 6 -7 years’ experience in similar role ideally in high volume manufacturing and/or Pharma/Medical Device industry
- Operational experience of high-purity process utility systems
- Detailed working knowledge of PLC/SCADA automation systems including execution of FAT and SAT testing
- At least five years engineering management experience in an FDA regulated GMP environment (Pharma/Med Device) and a record of achievement operating at a comparable level in a manufacturing environment
- Understanding of GMP, commissioning and validation activities
- Strong people & project management skills and be able to manage multiple vendors and contractors.
- Experience with CAD tools and drawing change control
- Structured approach to operation/capacity optimization, failure analysis and problem solving
- Practical application of statistical analysis techniques
- Knowledge of lean and 6-Sigma methodologies an advantage