HVAC Engineer

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.