CQV Engineer - HVAC & Clean Rooms
Location: Dublin, Ireland
Contract: 12 Months
Rate: €52.00 per hour
We are seeking an experienced CQV Engineer to support the commissioning and qualification of HVAC systems and GMP Clean Rooms within a sterile pharmaceutical manufacturing facility.
Key Responsibilities
- Develop and execute CQV protocols for HVAC systems, Clean Rooms and Cold Rooms.
- Execute Environmental Monitoring Performance Qualification (EMPQ) protocols and associated sampling.
- Coordinate CQV activities with vendors, contractors, Engineering, Quality and laboratory teams.
- Review laboratory results and analyse EMPQ data.
- Manage qualification deviations, investigations and associated corrective actions.
- Identify CQV risks and implement appropriate mitigation plans.
- Prepare qualification documentation and validation summary reports.
- Ensure activities comply with GMP, EU/FDA requirements and site procedures.
Requirements
- 3-5 years' C&Q/CQV experience within pharmaceutical or biopharmaceutical manufacturing.
- Hands-on experience qualifying HVAC systems and GMP Clean Rooms.
- Experience within sterile Drug Product or Drug Substance manufacturing.
- Experience preparing and executing CQV documentation.
- Knowledge of EMPQ / environmental monitoring qualification.
- Strong understanding of GMP and validation requirements.
- Kneat or ValGenesis experience is advantageous but not essential.
- Bachelor's degree in Engineering, Science or a related technical discipline.
