JOB SUMMARY
The Senior CQV HVAC Engineer plays a critical role in the planning, execution, and oversight of Commissioning, Qualification, and Validation (CQV) activities for HVAC systems within regulated environments, such as pharmaceutical, biotechnology, or life sciences facilities.
The engineer is responsible for ensuring that all HVAC systems are designed, installed, commissioned, qualified, and validated in compliance with industry standards, project requirements, and regulatory guidelines.
This senior role also provides technical leadership, supports project delivery, and mentors junior team members.
MAIN RESPONSIBILITIES
Lead and manage CQV activities for HVAC systems, including development of qualification protocols (DQ, IQ, OQ, PQ), commissioning plans, and validation reports.
Review and approve engineering documentation, drawings, specifications, and change controls related to HVAC systems.
Oversee and coordinate testing, inspection, and performance verification of cleanroom and critical environment HVAC systems.
Collaborate with multidisciplinary teams including project managers, design engineers, construction personnel, and quality assurance.
Ensure all work is performed in accordance with client requirements, cGMP, FDA, EU Annex 15, ASHRAE, ISO *****, and applicable regulatory standards.
Troubleshoot and resolve technical challenges related to system installation, performance, and compliance.
Prepare and present project status, technical findings, and compliance documentation to stakeholders and regulatory authorities.
Mentor and provide technical guidance to junior CQV engineers and other team members.
Participate in risk assessments, impact assessments, and change management processes.
Support project scheduling, budget tracking, and resource allocation for CQV HVAC activities.
Ensure robust and traceable documentation of all commissioning, qualification, and validation stages.
EDUCATION/QUALIFICATIONS
Bachelor's or Master's degree in Mechanical Engineering, Building Services, Chemical Engineering, or related discipline.
Minimum 7 years' experience in CQV for HVAC systems within pharmaceutical, biotechnology, or similarly regulated sectors.
Deep understanding of HVAC design, operation, and regulatory compliance in cleanroom and critical environment applications.
Proven experience developing and authoring DQ, IQ, OQ, PQ protocols, as well as commissioning and validation documentation.
Working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, and international standards (e.g., ISO *****, ASHRAE).
Experience in leading multidisciplinary project teams and delivering complex CQV programs on time and within budget.
Strong troubleshooting, analytical, and problem-solving skills.
Excellent written and verbal communication abilities; able to clearly convey technical and compliance information.
Proficiency with relevant software (e.g., AutoCAD, MS Office, project management tools).
Ability to travel and work on-site as required for project needs.
Relevant professional certifications (e.g., ASHRAE, ISPE, PMP) are an advantage.