EQUIPMENT & FACILITY QUALIFICATION ENGINEER
Responsibilities:
- 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.
- Generation of Commissioning Test documents for No Impact Systems.
- Implementation of Change Controls on the change management system to support project activities as applicable.
- 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.
- Developing a project plan and qualification strategy in line with Abbvie requirements.
- Project activities may include but not are not limited to the following: Medical Device assembly equipment, Utilities, HVAC & Facilities.
- Coordinate and supervise third party suppliers / vendors, service providers and sub-contractors as necessary.
- 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.
- Organise and or attend any necessary meetings that are required for progress gathering or plan alignment
- Participate in decision forums to decide on priorities and ensure these are reflected in the plan, schedule and communications.
- Where needed evaluate allocation of resources needed to complete project tasks and provide recommendations to maintain required progress.
- To communicate with project stakeholders required support and completion dates.
- If assigned a budget for project execution: Monitor budgets closely reporting on funding committed, expenditure forecasting and progress.
Requirements:
- Degree in Engineering or related discipline is a necessary requirement for this position with project management experience.
- Good interpersonal and coordination skills
- 5 years' experience in projects in the Pharmaceutical or BioTech /Medical devices sector or Major project environment.
- Knowledge & experience of, Microsoft Project , Good computer literacy including MS office and excel
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