Description
Clean Utilities Engineer
Team Horizon is seeking a Clean Utilities Engineer for a leading manufacturing company in Sligo.
Why you should apply:
1. You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo.
2. Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
3. Provide technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment and controls.
4. The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant.
5. This position requires developing and implementing changes that will improve equipment performance and consequently product quality.
6. To ensure continual compliance with the policies relating to Personnel, Quality, Engineering, Safety and Finance.
7. The Clean Utilities Engineer will take ownership for clean utilities (Purified Water, Water for Injection, Clean Steam, High Quality Compressed Air and Nitrogen Distribution) and to work as a team member in line with all safety, regulatory and organizational requirements.
8. Clean Utility Engineering Subject Matter Expert from design phase to equipment handover.
9. Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
10. SME in mechanical, electrical and pneumatic utility systems.
11. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
12. Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.
13. Delivery of safety, performance and quality goals.
14. Support clean utility equipment installation, integration and co-ordinate vendor supervision as required.
15. Develop and modify procedures as needed to support the clean utility area.
16. 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.
17. Participate and lead clean utility project implementations.
18. Leadership of clean utility and validation activities during project life cycle.
19. Investigate process exceptions or equipment malfunction incidents affecting the process.
20. To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, trouble shooting and installing/commissioning equipment.
21. Support the Production Team in ensuring that utility equipment is maintained to meet requirements.
22. Present on clean utility area in regulatory inspections ensuring successful outcomes.
23. Cross functional collaboration with QC Micro, Operations, QA and Engineering.
24. Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;
25. Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
26. Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
27. Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
28. Attend all required EHS training and medical surveillance programs.
29. All other duties as requested or assigned.
What you need to apply:
30. A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
31. At least five years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
32. At least three years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
33. Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
34. Experience in clean utilities is essential.