HVAC Team Leader – Pharmaceutical Cleanroom Operations

About the role

The HVAC Team Leader will head a group of engineers and technicians responsible for the operation, maintenance, and continuous improvement of HVAC systems that support sterile pharmaceutical manufacturing environments. This position ensures environmental control, regulatory compliance, and system reliability across classified cleanrooms and aseptic processing areas.

Key responsibilities

• Supervise daily activities of the HVAC team, assign and prioritize preventive, corrective, and predictive maintenance tasks.
• Maintain consistent temperature, humidity, pressure differentials, airflow direction, and particle levels in cleanrooms (Grades A‑D).
• Oversee performance of Air Handling Units, terminal HEPA filters, LAF units, and pressure cascade systems.
• Ensure all HVAC work complies with cGMP, EU GMP Annex 1, FDA 21 CFR, WHO, and related standards.
• Lead audit readiness and support internal/external inspections (USFDA, EMA, MHRA, etc.).
• Monitor BMS trends and EMS data, conduct root‑cause analysis, and implement CAPA.
• Provide engineering input for new HVAC designs, review P&IDs, control logic, and commissioning documents.
• Develop and enforce SOPs, work instructions, and maintenance documentation in GMP‑compliant systems.

Required profile

• Bachelor’s degree in Mechanical Engineering, HVAC Engineering, or a related field.
• Minimum 7 years of progressive experience with pharmaceutical HVAC systems and cleanroom environments.
• Proven leadership experience managing cross‑functional HVAC teams in high‑pressure, regulated settings.

Required skills

• HVAC system design, operation, and qualification (DQ, IQ, OQ, PQ).
• Terminal HEPA filtration and airflow visualization.
• Building Management System (BMS) monitoring and Environmental Monitoring System (EMS) data analysis.
• Cleanroom environmental control (temperature, humidity, pressure differentials).
• Regulatory compliance knowledge (cGMP, EU GMP Annex 1, FDA 21 CFR, WHO).
• Review of technical drawings (P&IDs, HVAC layouts) and control logic.