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.
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.
Location:
On-site Cork, Ireland
If this job description resonates with you, we encourage you to apply even if you don't meet all of the requirements.