EQUIPMENT & FACILITY QUALIFICATION ENGINEER
Responsibilities:
1. Generation, Execution / Approval of Qualification Life Cycle documents from System Classification, P/GURS, Risk Assessments / FMEA through to IOQ and Final Summary Reporting for Direct Impact Systems.
2. Generation of Commissioning Test documents for No Impact Systems.
3. Implementation of Change Controls on the change management system to support project activities as applicable.
4. The role requires someone to coordinate and manage all elements of commissioning & qualification of new and existing cleanroom facilities and automated medical device assembly equipment.
5. Developing a project plan and qualification strategy in line with Abbvie requirements.
6. Project activities may include but not are not limited to the following: Medical Device assembly equipment, Utilities, HVAC & Facilities.
7. Coordinate and supervise third party suppliers / vendors, service providers and sub-contractors as necessary.
8. Monitor and report on project plan progress, communicate any shortfalls in specific areas of the plan and where needed identify solutions to address the shortfalls.
9. Organise and or attend any necessary meetings that are required for progress gathering or plan alignment
10. Participate in decision forums to decide on priorities and ensure these are reflected in the plan, schedule and communications.
11. Where needed evaluate allocation of resources needed to complete project tasks and provide recommendations to maintain required progress.
12. To communicate with project stakeholders required support and completion dates.
13. If assigned a budget for project execution: Monitor budgets closely reporting on funding committed, expenditure forecasting and progress.
Requirements:
14. Degree in Engineering or related discipline is a necessary requirement for this position with project management experience.
15. Good interpersonal and coordination skills
16. 5 years' experience in projects in the Pharmaceutical or BioTech /Medical devices sector or Major project environment.
17. Knowledge & experience of, Microsoft Project, Good computer literacy including MS office and excel
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