CQV Engineer – HVAC & Clean Rooms

Next Generation; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Next Generation seeks an experienced CQV Engineer to support commissioning and qualification of HVAC systems and GMP Clean Rooms in a sterile pharmaceutical manufacturing facility.

You will develop CQV protocols, execute EMPQ testing, and coordinate CQV activities with cross-functional teams to ensure GMP compliance and site procedures are followed.

Qualifications

• 3–5 years' C&Q/CQV experience in pharmaceutical or biopharm manufacturing.
• Hands-on qualification of HVAC systems and GMP Clean Rooms.
• Experience in sterile drug product or drug substance manufacturing.
• Experience preparing and executing CQV documentation.
• Knowledge of EMPQ / environmental monitoring qualification.

Responsibilities

• Develop and execute CQV protocols for HVAC, Clean Rooms and Cold Rooms.
• Execute EMPQ protocols and associated sampling.
• Coordinate CQV activities with vendors, engineering, QA and labs.
• Review lab results and analyse EMPQ data.
• Manage deviations, investigations and CAPAs related to CQV.

Skills

CQV experience

HVAC qualification

GMP/Regulatory knowledge

Education

Bachelor's degree in Engineering/Science

Tools

Kneat

ValGenesis

Job description

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.