Job Description

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 

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