Quality Engineer

Prochem Engineering; Kilkenny; On-site; EUR 90,000 - 120,000; Full time

Job summary

Prochem Engineering is seeking a Quality Engineer to join a medical device manufacturing site in County Kilkenny. The role supports the Supplier Quality function across a diverse supplier base and will manage supplier non-conformances, change notifications, audits and validation support while driving supplier performance improvements.

You will lead a facilities team of 40+ and oversee site expansions, capital projects, and ensure GMP/EHS compliance while partnering with Operations, Quality,

Qualifications

• Degree in Engineering or related discipline.
• Significant facilities leadership experience in GMP manufacturing.
• Experience delivering facility expansions/upgrades in regulated environments.
• Experience managing critical utilities like HVAC, water, boilers, chillers, energy infrastructure.
• Strong leadership across large teams and multiple stakeholders.

Responsibilities

• Lead facilities operations across the site.
• Ensure reliability and compliance of site systems and assets.
• Manage facilities budgets and asset management plans.
• Drive continuous improvement in operations, sustainability, reliability, and cost.
• Lead a facilities team of 40+ and manage contractors.
• Support major site expansions and capital investment projects.
• Maintain GMP, EHS, regulatory standards and audits.
• Collaborate with Operations, Quality, Engineering, EHS, Supply Chain, and Finance.

Skills

Facilities leadership

People leadership

Budget management

Contractor management

Regulatory compliance

Education

Engineering degree

Job description

• Our client, based in County Kilkenny, is looking for a Quality Engineer to join the team at their medical device manufacturing site.
• This role supports the Supplier Quality function across a diverse supplier base.
• The successful candidate will manage supplier non-conformances, change notifications, audit activities and validation support, while driving supplier performance improvements.

Duties

• Lead all facilities operations, utilities, infrastructure, and engineering support services across the site
• Ensure the reliability, compliance, and performance of critical site systems and assets.
• Manage facilities budgets, asset management plans, contractor performance, and outsourced service providers
• Drive continuous improvement initiatives focused on operational excellence, sustainability, reliability, and cost optimisation
• Lead strategic discussions and influence decision-making across site functions, ensuring facilities priorities support broader business objectives
• Support the planning and delivery of major site expansion, infrastructure, and capital investment projects
• Explore innovative technologies, sustainability initiatives, and infrastructure solutions that enhance site capability and future readiness
• Maintain compliance with GMP, EHS, regulatory, and corporate standards
• Lead and develop a facilities organisation of 40+ employees and contractors, fostering a culture of accountability, collaboration, and continuous improvement
• Successfully manage multiple priorities, balancing day-to-day operational performance with long-term infrastructure planning and project delivery
• Build strong partnerships with Operations, Quality, Engineering, EHS, Supply Chain, and Finance teams
• Take initiative in identifying risks, opportunities, and investment needs to support site growth and operational excellence

Qualifications and Experience

• Degree in Engineering, Facilities Management, Building Services, Mechanical Engineering, Electrical Engineering, or a related discipline
• Significant facilities leadership experience within a Medical Device, Pharmaceutical, Life Sciences, or other GMP-regulated manufacturing environment
• Proven experience leading site-wide facilities, utilities, infrastructure, and engineering support functions
• Demonstrated experience delivering facility expansions, site development projects, infrastructure upgrades, or greenfield projects within a regulated manufacturing environment
• Experience managing critical utilities such as HVAC, water systems, compressed air, boilers, chillers, and energy infrastructure
• Strong contractor and outsourced service provider management experience
• Proven people leadership experience managing large teams and influencing across multiple stakeholder groups
• Experience managing operating budgets, capital planning, and infrastructure investment programmes
• Strong knowledge of GMP, quality, compliance, and EHS requirements
• Demonstrated ability to lead through change, navigate ambiguity, and deliver results in a fast-paced manufacturing environment

Preferred Experience:

• Experience delivering manufacturing expansion projects within Ireland
• Direct responsibility for capital projects valued at €5M+
• Experience delivering construction and expansion projects while maintaining manufacturing operations
• Exposure to FDA-regulated environments
• PMP, Prince2, Lean Six Sigma, or equivalent professional qualification