Job Description
PROCESS ENGINEER with experience of Sterile Manufacturing Operations, Syringe Filling and New Product Introduction required by CareerWise Recruitment for our multinational biopharmaceutical & medical device client in Waterford. Initial 12 month contract on offer.
The PROCESS ENGINEER wil have 3+ years experience and work on Projects / Programs associated with pre-filled syringe operations.
NOTE: It is essential that you hold a valid working visa for Ireland
Scope of works will involve, but is not limited to:
1. Filter test development
2. Fill weight cycle development
3. Cleaning verification
4. Documentation Generation/Execution eg. Recipe documents, FMEAs, Protocols, Reports etc.
5. Leading problem solving investigations for technical issues as well as owning change controls.
6. Delivering activities on schedule and within budget.
Responsibilities
7. Supporting day-to-day operations of the syringe filling area through investigations, identify and deliver corrective actions including continuous improvement projects.
8. Communicate and liaise with material/component vendors during project.
9. Execute Process Engineering activities to schedule and to the appropriate compliance and safety standards.
10. Writing of Process/Operational Control Strategy documents (detailing control over Critical Process Parameters), Failure Mode Effect Analysis (FMEA) and supporting Operator training.
11. Coordinating and ownership of deliverables to meet project timelines and cost.
12. Generation of hour-by-hour schedules for planning line time and execution of deliverables.
13. Provide support where required on the existing Aseptic Syringe Filling Line and supporting processes which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
14. Support commercial manufacturing through delivery of key performance metrics (SQDCI).
15. Role may require travel to other sites or vendor sites.
16. Participate in site GMP regulatory and safety audits.
17. Provide technical support to implement process improvements, new product transfers to the site and production.
Requirements:
18. Honours degree in an Engineering discipline.
19. Strong problem solving skills.
20. 3 or more years' relevant experience in a highly regulated GMP environment.
21. Experience of Sterile Manufacturing Operations would be an advantage.
22. Experience in syringe filling would be a distinct advantage.
23. Experience in new product introduction would be a distinct advantage.