Job Summary
A strategic, mission-critical position responsible for ensuring the operational excellence and regulatory compliance of building infrastructure in a pharmaceutical manufacturing facility.
This role directly impacts the production of life-saving medications by maintaining critical building systems, cleanroom environments, and controlled atmospheres that meet stringent FDA, EMA, and HPRA standards.
* Lead comprehensive facilities programs for a large-scale pharmaceutical manufacturing facility, including HVAC systems, cleanroom environments, controlled atmospheres, and critical utility systems to ensure 99.9%+ uptime for production operations.
* Develop, implement, and continuously optimize preventive maintenance strategies using risk-based methodologies, ensuring all building systems support GMP/GDP compliance and minimize unplanned downtime that could impact drug production.
* Manage emergency response protocols for critical building system failures, coordinating rapid resolution of issues affecting cleanroom classifications, environmental controls, and manufacturing-critical infrastructure with minimal production impact.
* Oversee vendor management and contractor coordination for specialized pharmaceutical facility services, including qualification of suppliers, performance monitoring, and ensuring all external maintenance activities meet life sciences regulatory requirements.
* Ensure strict adherence to regulatory compliance standards (FDA, EMA, HPRA) through meticulous documentation, validation of building system performance, and maintenance of qualification status for all facility infrastructure supporting drug manufacturing.
* Lead annual planning and cost optimization initiatives for building maintenance operations, developing strategic spending plans that balance regulatory compliance, operational efficiency, and capital expenditure requirements while achieving targets.
* Champion health & safety excellence by conducting comprehensive risk assessments, implementing safety protocols for maintenance activities in pharmaceutical environments, and ensuring team compliance with both industry and client safety standards.
* Maintain detailed documentation and reporting systems including maintenance records, compliance audits, system performance metrics, and regulatory inspection readiness documentation to support FDA/EMA inspections and internal quality reviews.
* Collaborate cross-functionally with Production, Quality Assurance, Engineering, and Regulatory Affairs teams to align building maintenance activities with manufacturing schedules and regulatory requirements.
* Lead and develop a high-performing maintenance team through coaching, training, and performance management while fostering a culture of continuous improvement and regulatory excellence.
* Manage capital improvement projects for building infrastructure upgrades, ensuring projects meet pharmaceutical design standards, regulatory requirements, and are delivered on time and within budget.
* Conduct regular facility condition assessments and develop long-term building maintenance strategies that anticipate equipment lifecycle needs and support facility expansion or modernization plans.
Requirements
* Education: Bachelor's degree in Mechanical Engineering, Electrical Engineering, Facilities Management, or related technical discipline.
* Experience: Minimum 7-10 years of building maintenance experience in pharmaceutical, biotechnology, or medical device manufacturing environments, 5+ years of leadership experience managing maintenance teams in regulated life sciences facilities.
* Regulatory & Industry Knowledge: Deep understanding of Irish building regulations, EU pharmaceutical regulations, and international GMP/GDP standards, experience with cleanroom classifications and critical utility systems.
* Certifications (Preferred): Certified Maintenance & Reliability Professional (CMRP), Project Management Professional (PMP) or equivalent, Irish Safe Pass certification, HVAC/refrigeration technician certifications.