HVAC CQV Engineer

EFOR; Limerick; On-site; EUR 70,000 - 110,000; Full time

Job summary

EFOR is seeking an experienced CQV HVAC Engineer to support Commissioning, Qualification, and Validation activities on complex pharmaceutical, biotechnology, or life sciences projects.

The candidate will develop and execute CQV plans for HVAC systems, lead field commissioning, and document qualification activities in GMP-regulated environments, interfacing with multi-disciplinary teams to ensure compliance with ISO 14644 and EU GMP Annex 1.

Qualifications

• Bachelor’s degree in Mechanical/Building Services Engineering or related field.
• Minimum of 5 years’ experience in Commissioning, Qualification, and Validation of HVAC systems within GMP-regulated environments.
• Proven track record in leading CQV activities for HVAC equipment, cleanrooms, and critical support systems.
• Deep understanding of cleanroom classifications and relevant guidelines (ISO 14644, EU GMP Annex 1).

Responsibilities

• Develop and execute CQV protocols (FAT, SAT, DQ, IQ, OQ, PQ) for HVAC systems, including AHUs and ductwork.
• Lead field commissioning activities including equipment inspection, system start-up, functional testing, and troubleshooting.
• Perform qualification for environmental parameters (temperature, humidity, differential pressure) and cleanrooms.
• Generate and review CQV documentation (protocols, reports, SOPs).
• Ensure activities align with GMP, ISO 14644, and project specifications; support regulatory audits.
• Interface with engineering, construction, automation, facilities, and QA/QC teams to coordinate issues.
• Identify, log, and resolve changes/deviations during HVAC qualification and validation.

Skills

HVAC Systems

CQV Execution

Documentation

Team Collaboration

Regulatory Compliance

Education

Bachelor’s degree in Mechanical Engineering

Tools

BMS

Air Balancing Equipment

QA/QC Software

Job description

We are seeking an experienced CQV HVAC Engineer to support Commissioning, Qualification, and Validation activities on complex pharmaceutical, biotechnology, or life sciences projects. The ideal candidate will have a minimum of 5 years’ hands-on experience with HVAC systems in GMP-regulated environments, possessing deep technical knowledge of HVAC system design, installation, and qualification processes. The role will focus on ensuring all HVAC-related systems are installed, commissioned, and qualified in compliance with project, regulatory, and industry requirements.

Key Responsibilities

CQV Planning & Execution:

• Develop and execute CQV protocols (FAT, SAT, DQ, IQ, OQ, and PQ) related to HVAC systems, including AHUs, terminal HEPA filters, ductwork, and Building Management Systems (BMS).
• Lead field commissioning activities including equipment inspection, system start-up, functional testing, and system troubleshooting for HVAC-related components.

Qualification Activities:

• Perform and document qualification work for critical environmental parameters (e.g., temperature, humidity, differential pressure), air change rates, and classification of cleanrooms.

Documentation:

• Generate and review all related CQV documentation, including protocols, reports, SOPs, and supporting technical documents.

Regulatory Compliance:

• Ensure all activities align with current GMP, ISO 14644, GEP, and project specifications, supporting regulatory audits as necessary.

Cross-Functional Collaboration:

• Interface closely with engineering, construction, automation, facilities, and QA/QC teams to coordinate and resolve HVAC system issues.

Change & Deviation Management:

• Identify, log, and support resolution of changes, deviations, and non-conformances during HVAC qualification and validation.
• Capture and implement CQV best practices and lessons learned to improve HVAC qualification processes.

Requirements

• Bachelor’s degree in Mechanical Engineering, Building Services Engineering, Chemical Engineering, or related discipline.
• Minimum of 5 years’ relevant experience in Commissioning, Qualification, and Validation of HVAC systems within GMP-regulated (pharma/biotech/life sciences) environments.
• Proven track record in leading CQV activities for HVAC equipment, cleanrooms, and critical support systems.
• Deep understanding of cleanroom classifications, aseptic facility requirements, and relevant guidelines (e.g., ISO 14644, EU GMP Annex 1).
• Strong knowledge of HVAC/BMS system architecture, automation, and functional testing methodologies.
• Exceptional attention to detail and thorough documentation skills.
• Familiarity with common industrial commissioning tools, field instruments, and test methods (e.g. air balancing, HEPA integrity testing, environmental monitoring).
• Excellent communication and team collaboration abilities.
• CQV-related industry certification (e.g., ISPE, ASHRAE) preferred.
• Experience supporting regulatory inspections (e.g., FDA, EMA).
• Experience with containment, isolation, or high-potency HVAC system design/qualification.