1. General Information:
Job Title: Site Utilities Engineer
Position Reports to: Site Utilities and Energy Lead
2. Job Purpose:
To provide Utilities Engineering expertise specifically for the major site mechanical systems e.g. HVAC, RO/WFI, Compressed Air, Gases, Steam, Fire, Life Safety Systems, Water etc. on the GC Site.
This role focuses on optimizing equipment and systems performance, improving reliability, driving continuous improvement, troubleshooting faultfinding, asset replacement planning, strategic planning for utilities and system capacity planning.
The job-holder works as part of a multi-functional Utilities team and will be expected to be familiar with the operation of building and centralized control systems and utilities control systems
This individual will need to be flexible and agile in support of the group’s overall mission.
The role will include reviewing compliance documentation and Regulatory Audit attendance
3. Job Responsibilities:
1. Be a system matter expert (SME) for all cGMP and non-cGMP systems Utility Systems across the site.
2. Assess required changes to the maintenance program and update as appropriate
3. Raise change Controls for changes to Utilities systems driven by the utilities team Investigate Calibration events and complete appropriate GMP documentation
4. Point of contact for Clean Utilities out of specifications and support the completion of investigations where appropriate
5. Implement CI projects on systems and ensure they are operating at optimum.
6. Approve systems changes under cGMP or GEP change management processes.
7. Gain a full understanding of the utilities systems interdependencies and the criticality of all GMP systems on site.
8. Generate and/or update Standard Operating Procedures or engineering work instructions as applicable
9. Complete GAP analysis on Pfizer corporate standards
10. Assist in the development of user requirement specifications to allow the replacement of assets, obtain funding and implement replacement projects.
11. Complete Periodic Reviews as necessary.
12. Be the lead investigator on manufacturing investigations where appropriate.
1. Minimum qualification Bsc or MSc/M.Eng Degree in Mechanical/Electrical or Building Services Engineering or equivalent
2. A minimum of 3 - 5 Years cGMP industrial experience, ideally covering Operations, Engineering, Projects and Validation within a manufacturing environment.
3. In depth understanding of Site Utilities Systems including HVAC, WFI/RO, gases, waste systems and Loss Prevention systems.
4. Have worked in a sustaining, operations and/or project role previously with extensive knowledge of how equipment design & handover should be influenced to improve reliability and start-up.
5. Have worked in a compliance environment and excel at generation of and completion of cGMP documentation.