Responsibilities:
1. To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
2. Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.
3. Owning and preparing preventative and predictive maintenance for new pharma equipment being installed and approval of these procedures on Maximo.
4. Completion and documentation of PM’s and pDM’s on manufacturing equipment into Maximo.
5. Owning and ensuring that commissioning spare parts are received and cataloged in Maximo.
6. Owning and ensuring that critical spare parts are identified and once received, cataloged in Maximo.
7. Active participation in Factory Acceptance Testing, Site Acceptance Testing, and commissioning and qualification of equipment.
8. Review and approve process-related commissioning, qualification, and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements.
9. Review and approve process flow diagrams (PFDs), specifications, layouts, and P&ID’s. Ensuring proactive high performance of day-to-day preventative and demand maintenance activity to maintain manufacturing and utility equipment.
10. Liaising with operations, quality, and technical operations to ensure equipment and process performance is maximized.
11. To maintain records and documentation on relevant Engineering Procedures and preventative/demand maintenance.
12. To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining troubleshooting, and installing/commissioning equipment.
13. Completion of instrument calibration as per schedule.
14. Take ownership of the site’s Predictive Maintenance program, through managing and developing the outsourced condition monitoring contracts, implementing recommendations, and tracking to closure.
15. Implementation of equipment/process upgrades in an environment of continuous improvement.
16. Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.
17. Adhering to all relevant policies relating to Quality & Safety.
18. Ensure successful external inspections, and Division and Corporate audits.
19. Supervision of external contractors.
Requirements:
1. Relevant Trade Qualification or engineering qualification to Cert level at a minimum (Diploma/Degree Preferred)
2. Minimum of 5 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment required
3. Proven problem-solving ability on complex equipment.
4. Proven instrumentation/PLC troubleshooting ability.
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