HVAC & Clean Room CQV Engineer — GMP Validation

Next Generation; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

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

You will develop CQV protocols for HVAC, Clean Rooms and Cold Rooms, execute EMPQ protocols and associated sampling, coordinate CQV activities with vendors, Engineering, Quality and laboratory teams, review results, and ensure compliance with GMP/EU/FDA requirements.

Qualifications

• 3–5 years' C&Q/CQV experience in pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience qualifying 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.
• GMP understanding and validation requirements.
• Kn ea t/ValGenesis experience is advantageous but not essential.
• Bachelor's degree in Engineering, Science or related discipline.

Responsibilities

• Develop and execute CQV protocols for HVAC systems, Clean Rooms and Cold Rooms.
• Execute 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 corrective actions.
• Identify CQV risks and implement mitigation plans.
• Prepare qualification documentation and validation summary reports.
• Ensure activities comply with GMP, EU/FDA requirements and site procedures.

Skills

CQV Engineer

HVAC qualification

GMP knowledge

Clean Room qualification

EMPQ qualification

Kneat/ValGenesis

Education

Bachelor's degree in Engineering/Science

Tools

Kneat

ValGenesis

Job description

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

You will develop CQV protocols for HVAC, Clean Rooms and Cold Rooms, execute EMPQ protocols and associated sampling, coordinate CQV activities with vendors, Engineering, Quality and laboratory teams, review results, and ensure compliance with GMP/EU/FDA requirements.