Equipment & Facility Qualification Engineer

Team Horizon is seeking a Equipment & Facility Qualification Engineer for a leading manufacturing company in Sligo.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.


• You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo.

What you will be doing:

• 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 company 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 stakholders required support and completion dates.


• If assigned a budget for project execution: Monitor budgets closely reporting on funding committed, expenditure forecasting and progress.


• And any other duties as assigned.

What you need to apply:

• 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.