Equipment & Facility Qualification Engineer

Desired Skills: Equipment Qualification Eng,Facilities,Project Engineer

PE Global is currently recruiting for an Equipment & Facility Qualification Engineer for a leading med device clients based in Sligo

This is an initial 12-month contract position.

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 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.
• Organize 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
• Team worker
• Project focused

Interested candidates should submit an updated CV.

Please click the link below to apply,  or alternatively send an up to date CV to rebecca@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***