Reporting to the Product Engineering Manager, this person is responsible for the planning, designing, coordinating, validating, and implementing of high technology equipment and/or processes for the production, finishing and inspection of IOLs and delivery system products. Provides engineering support to manufacturing to maintain high yields and minimize downtime of process equipment. Must also demonstrate analytical skills in problem solving.
1. Responsible for opening Change Controls
2. Responsible for completion of all required GxP validation assessments.
3. Responsible for preparing and gaining approval for the Project plan
4. Responsible for preparing and gaining approval for the Validation Plan
5. Responsible for coordination and completion of Risk Management documents and generation of all validation protocols.
6. Execute pre-validation studies as required
7. Equipment Validation and process validation protocol drafting
8. Manage and execute the equipment and process validations
9. Report to project manager on status of tasks.
10. Coordinate all necessary associate training and release the necessary production SOPs and associated documentation.
11. Generate all required validation reports
12. Liaise with manufacturing to ensure successful go-live of equipment.
13. Change Control Closure
Excellent organisation skills
Minimum: Bachelor degree in Engineering/ Physics or related discipline.
Preferred: Masters/ PhD degree in. Engineering/ Physics or related discipline.
Minimum: Demonstrated technical aptitude and competency. 2-5 years' experience in GMP manufacturing environment
Preferred: 5-10 years' experience in medical device manufacturing. Experience with metrology systems. Experience with cross-site projects and R&D Liaison. Project management experience. Regulated industry experience.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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