Job Description
As a key member of our engineering team, you will play a vital role in ensuring the smooth operation of pharma facilities.
Main Responsibilities:
1. Support engineering operations by adhering to safety, regulatory, and organizational requirements.
2. Participate 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 with approval on Maximo.
4. Complete and document PM's and PDM's on manufacturing equipment into Maximo.
5. Owning and ensuring commissioning spare parts are received and cataloged in Maximo.
6. Identifying and receiving critical spare parts, then cataloguing them 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.
10. Maintaining proactive high performance of day-to-day preventative and demand maintenance activity to maintain manufacturing and utility equipment.
11. Liaising with operations, quality, and technical operations to ensure equipment and process performance is maximized.
12. Maintaining records and documentation on relevant Engineering Procedures and preventative/demand maintenance.
13. Liaising with Internal/External Engineering Personnel and contract maintenance providers in maintaining troubleshooting and installing/commissioning equipment.
14. Completion of instrument calibration as per schedule.
15. Managing the site's Predictive Maintenance program, overseeing outsourced condition monitoring contracts, implementing recommendations, and tracking to closure.
16. Implementing equipment/process upgrades in an environment of continuous improvement.
17. Supporting the Production Team in ensuring manufacturing equipment meets output and yield requirements.
18. Adhering to all relevant policies relating to Quality & Safety.
19. Ensuring successful external inspections and Division and Corporate audits.
20. Supervising external contractors.
To be successful in this role, you will require:
* A relevant trade qualification or engineering qualification to Cert level at a minimum (Diploma/Degree preferred).
* Technical/business knowledge of at least 3 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment.
* Proven problem-solving ability on complex equipment.