CQV Engineer: HVAC & Clean Room for GMP Sterile

Next Generation; Dublin; Presencial; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Next Generation in Dublin is seeking an experienced CQV Engineer to support a major sterile drug product project. The role requires hands-on HVAC and GMP clean room qualification experience to ensure compliant commissioning and qualification deliverables.

You will develop and execute CQV protocols for HVAC, clean rooms and cold rooms, perform EMPQ activities, review data, and coordinate with cross-functional teams to meet EU/FDA requirements and site procedures.

Qualificações

• 3–5+ years' CQV experience in pharma/biopharma.
• Hands-on HVAC and Clean Room qualification experience.
• Experience within sterile Drug Product or Drug Substance manufacturing.
• Strong CQV protocol preparation and execution experience.
• EMPQ / environmental monitoring experience desirable.

Responsabilidades

• Develop and execute CQV protocols for HVAC systems, Clean Rooms and Cold Rooms
• Execute EMPQ protocols and sampling activities
• Perform/review HVAC and clean-room qualification testing and associated documentation
• Review environmental monitoring and laboratory data
• Manage CQV deviations, investigations and qualification issues
• Coordinate with vendors, contractors, Engineering, Quality and laboratory teams
• Prepare qualification and validation summary reports
• Ensure compliance with GMP, EU/FDA requirements and site procedures

Conhecimentos

CQV experience

HVAC qualification

Clean Room qualification

GMP knowledge

Documentation & QA

EMPQ experience

Kneat or ValGenesis

Formação académica

Engineering or science degree

Ferramentas

Kneat

ValGenesis

Descrição da oferta de emprego

Next Generation in Dublin is seeking an experienced CQV Engineer to support a major sterile drug product project. The role requires hands-on HVAC and GMP clean room qualification experience to ensure compliant commissioning and qualification deliverables.

You will develop and execute CQV protocols for HVAC, clean rooms and cold rooms, perform EMPQ activities, review data, and coordinate with cross-functional teams to meet EU/FDA requirements and site procedures.