CQV Engineer – HVAC & Clean Rooms

Next Generation; Dublin; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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

Connaissances

CQV experience

HVAC qualification

Clean Room qualification

GMP knowledge

Documentation & QA

EMPQ experience

Kneat or ValGenesis

Formation

Engineering or science degree

Outils

Kneat

ValGenesis

Description du poste

We are looking for an experienced CQV Engineer with hands-on HVAC and GMP Clean Room qualification experience to support a major sterile drug product manufacturing project in Dublin.

Key Responsibilities:

• Develop and execute CQV protocols for HVAC systems, Clean Rooms and Cold Rooms
• Execute Environmental Monitoring Performance Qualification (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

Experience & Qualification

• 3–5+ years' C&Q/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 highly desirable
• Engineering, Science or related technical degree
• Kneat or ValGenesis experience is an advantage