Building Lead Job Description
Provide 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 Responsibilities
Critical Systems Management:
* Operate pharmaceutical-grade systems including clean steam generators, Water for Injection (WFI) systems, compressed air, and nitrogen generation
* Maintain HVAC systems supporting classified cleanroom environments (ISO 5-8)
* Ensure 100% PPM compliance for GMP-critical equipment by month end
* Monitor and maintain environmental parameters (temperature, humidity, pressure differentials, particle counts)
Regulatory Compliance & Documentation:
* Ensure compliance with Irish Health Products Regulatory Authority (HPRA) requirements
* Maintain validation documentation and change control procedures
* Complete and update EHS documentation including delivery of tool box talks to engineering teams
* Support pharmaceutical audits and regulatory inspections
Team Leadership & Coordination:
* Coordinate and control Shift Engineers and specialized pharmaceutical technicians
* Manage annual leave scheduling ensuring continuous coverage of critical operations
* Maintain effective shift handovers including critical plant status, cleanroom classifications, and ongoing pharmaceutical production activities
Maintenance & Operations:
* Reactive works compliance – manage work orders within pharmaceutical SLA requirements
* Coordinate specialist pharmaceutical equipment service providers and validation activities
* Issue/Close work permits for pharmaceutical manufacturing areas including sterile zones, controlled substances areas, and hazardous material handling
* Maintain pharmaceutical-grade spare parts inventory and calibrated equipment records
About You
Essential Qualifications:
* 5+ years experience in pharmaceutical manufacturing or life sciences facilities
* HV/LV authorized person certification (training can be provided)
* C&G Parts 1 & 2 or equivalent in electrical/mechanical disciplines
* Current Edition IEE Wiring and Installation Regulations or equivalent mechanical engineering qualification
* Understanding of pharmaceutical Good Manufacturing Practice (GMP) requirements
* Experience with FDA/EMA validation protocols and pharmaceutical equipment qualification
Technical Competencies:
* Demonstrate technical competence in pharmaceutical utilities including UPS systems, emergency generators, clean steam, WFI systems, and pharmaceutical-grade compressed gases
* Experience with cleanroom HVAC systems, particle monitoring, and environmental controls
* Understanding of pharmaceutical water systems, bioburden control, and sanitization procedures
* Must have experience in critical facilities environments supporting pharmaceutical manufacturing
Leadership & Communication:
* Ability to lead, motivate and direct specialized pharmaceutical technicians and operatives
* Strong communication skills for interaction with pharmaceutical production teams, quality assurance, and regulatory personnel
* Experience working in high-pressure pharmaceutical manufacturing environments
* Comprehensive IT skills including pharmaceutical maintenance management systems