HVAC CQV Engineer - Cleanroom & GMP Validation Lead

Morgan McKinley; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking an experienced HVAC Engineer to drive CQV execution for critical HVAC and cleanroom systems at a premier manufacturing facility in Ireland. You will manage CQV activities from initiation through final validation reports, ensuring audit readiness.

You will lead EMPQ protocol execution, analyze data, and coordinate with vendors, contractors, and internal teams to deliver high-quality results in a fast-paced environment.

Qualifications

• 3-5 years of hands-on C&Q experience within a regulated sterile drug product, biopharmaceutical, or pharmaceutical environment including documentation and execution.
• Proven background in C&Q for sterile manufacturing HVAC systems, cleanrooms, cold rooms and integrated automation.
• Familiarity with digital validation execution software such as Kneat or ValGenesis is advantageous.

Responsibilities

• Develop and execute robust Commissioning, Qualification, and Validation (CQV) testing documentation for site HVAC and Cleanroom systems in alignment with safety, quality, and project schedule milestones.
• Lead Environmental Monitoring Performance Qualification (EMPQ) protocol execution, including physical sampling, laboratory data review, and analytical data interpretation.
• Ensure all GMP cleanrooms, cold rooms, and HVAC equipment comply strictly with local site procedures, global quality guidelines, and EU/FDA regulatory standards.
• Proactively identify and categorize CQV risks, generate mitigation action plans, and lead deviation investigations associated with assigned cleanrooms and utilities.
• Coordinate seamless site execution alongside equipment vendors, external contractors, laboratories, and internal cross-functional project teams.
• Prepare comprehensive validation summary reports and manage project electronic records to maintain full audit readiness.

Skills

CQV experience

Analytical skills

Written and verbal communication

Team collaboration

Education

BSc / BEng / MSc in Engineering, Scientific, or technical discipline

Tools

Kneat

ValGenesis

Job description

Morgan McKinley is seeking an experienced HVAC Engineer to drive CQV execution for critical HVAC and cleanroom systems at a premier manufacturing facility in Ireland. You will manage CQV activities from initiation through final validation reports, ensuring audit readiness.

You will lead EMPQ protocol execution, analyze data, and coordinate with vendors, contractors, and internal teams to deliver high-quality results in a fast-paced environment.