Essential Duties and Responsibilities:
1. Plan and lead team of engineers in commissioning and qualification CIP systems.
2. Plan and lead team of engineers in completing hydraulic balancing of CIP.
3. Liaise and coordinate CIP testing activities with other system owners to ensure CIP testing meets schedule requirements.
4. Participate in design document reviews and ensure that quality aspects are included in design.
5. Attend FAT and execution of agreed testing protocols and sign off on permission to ship forms.
6. Generate CQV documents at project level and for specific equipment/systems. Liaising with Quality, Engineering and CQV to align on Critical parameters and document content.
7. Work with the automation teams, ensure that process descriptions are provided, and Functional Specs are reviewed and approved to ensure that the automation element of the project meets schedule.
8. Track and confirm closure of actions items identified through FAT, HAZOP, Design Qualification and other reviews.
9. Maintain a strong interface with the Automation and Engineering teams to ensure that the information flow meets the needs of the Automation and Engineering teams, resolving issues as they arise.
10. Participate in construction system completion walkdowns.
11. Coordinate and lead team of shift C&Q engineers in the execution of commissioning, cycle development and shakedown activities.
12. Perform shakedown and commissioning and qualification of systems.
13. Introduce caustic to CIP skids and oversee safe use of caustic in cleaning cycle development.
14. Oversee cycle development of cleaning cycles to reduce caustic concentration to acceptable levels.
Requirements:
15. B.Sc/B.Eng. degree in engineering discipline, with particular emphasis mechanical or process engineering.
16. Extensive experience from biotechnology or pharmaceutical GMP manufacturing/CQV environment.
17. Experienced in commissioning and qualifying CIP systems.
18. Experienced in leading teams of engineers.
19. Demonstrated ability to work on own initiative and proactively respond to business needs.
20. Excellent interpersonal and communication skills.
21. Familiar with Delta-V & Navis Works an advantage.
If this role is of interest to you, please apply now
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