SUMMARY
The Equipment & Facility Qualification Engineer is responsible for coordinating and managing all elements of commissioning and qualification of new and existing cleanroom facilities and automated medical device assembly equipment. The role involves developing project plans, ensuring compliance with regulatory requirements, and managing vendor and contractor activities to support successful project execution.
RESPONSABILITIES
Qualification & Commissioning:
* Generate, execute, and approve Qualification Life Cycle documents, including:
* System Classification
* P/GURS
* Risk Assessments / FMEA
* IOQ and Final Summary Reports for Direct Impact Systems
* Prepare Commissioning Test documents for No Impact Systems.
* Implement Change Controls in the change management system to support project activities.
Project Management:
* Develop project plans and qualification strategies in line with company requirements.
* Coordinate project activities, which may include Medical Device Assembly Equipment, Utilities, HVAC, and Facilities.
* Supervise third-party suppliers, vendors, service providers, and subcontractors.
* Monitor and report on project progress; identify and resolve shortfalls.
* Organize and attend meetings for progress updates and plan alignment.
* Participate in decision-making forums to set priorities and update schedules.
* Evaluate resource allocation and provide recommendations to maintain progress.
* Communicate project requirements and completion timelines to stakeholders.
* If assigned a budget, monitor and report on funding, expenditures, and progress.
Preferred Skills:
* Ability to handle challenging situations effectively.
* Strong problem-solving skills.
* Self-motivated and proactive.
* Adherence to targets and deadlines.
Requirements:
* Degree in Engineering or related discipline with project management experience.
* Minimum of 5 years' experience in
Medical Devices
, Biotech, Pharmaceutical, or major project environments.
* Experience completing
system risk assessments
.
* Proficiency in Microsoft Project and strong computer literacy (MS Office and Excel).
* Strong team player with a project-focused mindset.
* Solid understanding of systems, equipment, and engineering design principles.
Apply today
Our Vision:
To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters
For further information on this role please contact
Róisín Vaughan
on
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