We are seeking a skilled and motivated Equipment & Facility Qualification Engineer to lead and execute commissioning and qualification activities for cleanroom facilities and automated medical device assembly equipment. This role requires strong project management skills, hands-on technical experience, and the ability to work in a fast-paced, regulated environment.

KEY RESPONSIBILITIES:

• Prepare, execute, and review qualification lifecycle documentation (e.g., system classification, URS, risk assessments/FMEA, IOQ, summary reports) for direct impact systems.
• Create commissioning documentation for non-impact systems.
• Manage and implement change controls in support of project activities.
• Develop and execute qualification strategies for cleanroom environments, utilities, HVAC systems, and medical device equipment.
• Supervise and coordinate third-party vendors, contractors, and service providers.
• Track project progress against plan; escalate shortfalls and propose corrective actions.
• Facilitate or attend relevant project meetings and alignment sessions.
• Prioritize tasks and resources to maintain project momentum and compliance.
• Provide clear communication to stakeholders on timelines, dependencies, and resource needs.
• If managing budgets, track expenditures, forecast costs, and report on financial status.

QUALIFICATIONS & EXPERIENCE:

• Degree in Engineering or related technical discipline.
• Minimum 4 years' experience in equipment/facility qualification projects within pharmaceutical, biotech, or medical device industries.
• Proficiency with Microsoft Project and strong MS Office/Excel skills.
• Experience in project management and cross-functional team collaboration.
• Solid understanding of GMP, ISO standards, and qualification/validation best practices.

KEY COMPETENCIES:

• Technical understanding of equipment, facilities, and system design principles.
• Clear and timely communication with internal and external stakeholders.
• Adaptability to shifting priorities, project scopes, and working methods.
• Ability to manage multiple tasks simultaneously in a dynamic environment.
• Demonstrates integrity, professionalism, and a commitment to quality.
• Strong written and verbal communication skills.

LEADERSHIP & COLLABORATION:

• May lead cross-functional teams and support cost improvement initiatives.
• Provides technical leadership and knowledge transfer during project handovers.
• Supports stakeholder engagement and effective communication throughout the project lifecycle.

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 086 440 3742 / consult@hero.ie

Check out all our open jobs on our HERO Recruitment website - HERO Recruitment: Leading STEM Recruitment Agency 

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.