Job Title
We are seeking an experienced Senior Process Engineer to join our team. The successful candidate will have a strong background in biopharmaceuticals and a proven track record of establishing manufacturing technology teams in large-scale facilities.
Job Description:
The Senior Process Engineer will play a pivotal role in establishing our Manufacturing Technology team. Key responsibilities include providing engineering support for ongoing requirements, leading future tech transfer projects, and championing continuous improvements using PI tools and techniques.
The ideal candidate will have excellent communication skills, computer literacy, and the ability to work independently and as part of a team. A thorough knowledge of current Good Manufacturing Practices (cGMP) is essential, with experience and knowledge of Delta V MCS platform preferred.
1. Assist in site start up and project related activities
2. Support package owners on vendor management and equipment or process related activities and queries
3. Generate equipment verification & validation protocols and reports as required
4. Review vendor documentation for completeness and accuracy
5. Participate in FAT and vendor related activities
6. Support issue resolution during equipment installation, commissioning and qualification phases
7. Participate/Execute/Lead verification & validation related activities as required
8. Support CQV execution team as needed
9. Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state
10. Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit
11. Main point for communications with the Core Engineering group for MFG 7
12. Implement equipment CAPAs and performance improvements Execute and lead equipment verification, validation & revalidation protocols as required
13. Provide equipment technical support and troubleshooting
14. Provide routine Automation support, troubleshooting and maintenance
15. Champion and drive the implementation of Global Requirement Program tools and techniques within the Operation Unit
16. Drive the use of PI to provide business efficiency Identify equipment improvement projects for Core Engineering Unit
17. Work with the portfolio management process to identify projects/support demands from the Core Units
18. Champion and Support Energy saving programs/projects within the Operating Unit
19. Write equipment assessments to support investigation closure
20. Conduct Investigation Trending
21. Change Control write up and close out
22. Lead / provide SME input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations including authoring investigation reports, technical assessments and summaries
23. Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented
24. Participate in cross-functional project teams as applicable
25. Provide input and work with the MFG leadership team to deliver the MFG objectives
26. Support audit preparation
27. Coach manufacturing team on Op Ex tools and use OE systems as the basis for identifying improvements
28. Implement and support continuous improvements that reduce cycle times and operational costs
29. Coach production personnel in manufacturing equipment as required
30. Developing and maintaining a database for investigations, or other required department tracking and data analysis needs, as applicable
31. Complete biennial review and PQS updates
32. Support the disposition process
33. Ensure all data ready in timely fashion in support of Opu disposition metric
34. Perform all duties in accordance with GMP requirements, SOPs and controlled documents
35. Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Technology Lead
36. Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the Wu Xi corporate core values and PROUD culture