Facilities & Equipment Engineer

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 commisioning & qualification of new and existing cleanroom facilitties and automated medical device assembly equipment.

·        Developing a project plan and qualification startegy 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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