Job Description
Building Lead Job DescriptionProvide comprehensive engineering support for pharmaceutical manufacturing facilities, maintaining critical infrastructure systems essential to drug production and research operations. Maintain detailed understanding of all Building Services systems, cleanroom environments, and contingency procedures while ensuring compliance with pharmaceutical industry regulations, FDA/EMA guidelines, and Irish statutory requirements.Act as coordination point for day-to-day activities between engineering teams, pharmaceutical production staff, specialist service partners, and validation projects. Ensure all personnel maintain the highest standards of safety, professionalism, and regulatory compliance critical to pharmaceutical manufacturing operations.Responsible for ensuring 100% uptime of critical systems supporting pharmaceutical production, including HVAC, clean utilities, process cooling, and environmental monitoring systems. Maintain shift coordination to support continuous manufacturing operations and ensure compliance with Good Manufacturing Practice (GMP) requirements.Key ResponsibilitiesCritical Systems Management:Operate pharmaceutical-grade systems including clean steam generators, Water for Injection (WFI) systems, compressed air, and nitrogen generationMaintain HVAC systems supporting classified cleanroom environments (ISO 5-8)Ensure 100% PPM compliance for GMP-critical equipment by month endMonitor and maintain environmental parameters (temperature, humidity, pressure differentials, particle counts)Regulatory Compliance & Documentation:Ensure compliance with Irish Health Products Regulatory Authority (HPRA) requirementsMaintain validation documentation and change control proceduresComplete and update EHS documentation including delivery of tool box talks to engineering teamsSupport pharmaceutical audits and regulatory inspectionsTeam Leadership & Coordination:Coordinate and control Shift Engineers and specialized pharmaceutical techniciansManage annual leave scheduling ensuring continuous coverage of critical operationsMaintain effective shift handovers including critical plant status, cleanroom classifications, and ongoing pharmaceutical production activitiesMaintenance & Operations:Reactive works compliance – manage work orders within pharmaceutical SLA requirementsCoordinate specialist pharmaceutical equipment service providers and validation activitiesIssue/Close work permits for pharmaceutical manufacturing areas including sterile zones, controlled substances areas, and hazardous material handlingMaintain pharmaceutical-grade spare parts inventory and calibrated equipment recordsAbout YouEssential Qualifications:5+ years experience in pharmaceutical manufacturing or life sciences facilitiesHV/LV authorized person certification (training can be provided)C&G Parts 1 & 2 or equivalent in electrical/mechanical disciplinesCurrent Edition IEE Wiring and Installation Regulations or equivalent mechanical engineering qualificationUnderstanding of pharmaceutical Good Manufacturing Practice (GMP) requirementsExperience with FDA/EMA validation protocols and pharmaceutical equipment qualificationTechnical Competencies:Demonstrate technical competence in pharmaceutical utilities including UPS systems, emergency generators, clean steam, WFI systems, and pharmaceutical-grade compressed gasesExperience with cleanroom HVAC systems, particle monitoring, and environmental controlsUnderstanding of pharmaceutical water systems, bioburden control, and sanitization proceduresMust have experience in critical facilities environments supporting pharmaceutical manufacturingLeadership & Communication:Ability to lead, motivate and direct specialized pharmaceutical technicians and operativesStrong communication skills for interaction with pharmaceutical production teams, quality assurance, and regulatory personnelExperience working in high-pressure pharmaceutical manufacturing environmentsComprehensive IT skills including pharmaceutical maintenance management systems
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