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