Quality Engineer

Prochem Engineering; Kilkenny; On-site; EUR 70,000 - 110,000; Full time

Job summary

Prochem Engineering is seeking a Quality Engineer to support supplier quality and lead facilities operations at a medical device site in Ireland. The role involves managing supplier non-conformances, change notifications, audits and validation support while driving supplier performance improvements.

As a leader of a 40+ person facilities team, you will oversee utilities, infrastructure and engineering services, ensuring GMP, EHS and corporate standards are met, and you will drive cost

Qualifications

• Degree in engineering or related discipline.
• Significant facilities leadership experience in GMP-regulated manufacturing.
• Experience leading site-wide facilities, utilities, infrastructure, and engineering support functions.
• Experience delivering facility expansions or capital projects in regulated environments.
• Strong knowledge of GMP, quality, compliance and EHS requirements.

Responsibilities

• Lead facilities operations, utilities, infrastructure and engineering services across the site.
• Maintain compliance with GMP, EHS and regulatory standards.
• Manage budgets, asset plans, contractor performance, and outsourced services.
• Drive continuous improvement in operations, sustainability, reliability and cost.
• Lead a facilities organisation of 40+ personnel and contractors.

Skills

Leadership

Stakeholder management

Budget management

Regulatory compliance

Change management

Education

Engineering degree

Tools

PMP

Prince2

Lean Six Sigma

Job description

Role Purpose

• 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

Essential 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