Job Description

Position Summary:
The HVAC Team Leader - Sterile Manufacturing will lead a team of engineers and technicians responsible for the operation, maintenance, and continuous improvement of HVAC systems supporting sterile pharmaceutical manufacturing environments. This role is critical for ensuring environmental control, regulatory compliance, and system reliability across classified cleanrooms and aseptic processing areas.
Key Responsibilities:
Leadership & Team Management

• Supervise and coordinate the daily activities of the HVAC team, ensuring optimal system performance in aseptic and sterile zones.
• Assign and prioritize tasks related to preventive, corrective, and predictive maintenance of HVAC systems.
• Mentor, train, and evaluate HVAC technicians and junior engineers to uphold high technical and compliance standards.

Sterile Area HVAC Management

• Ensure consistent environmental control in cleanrooms (Grade A/B/C/D), including temperature, humidity, differential pressure, airflow direction, and particle levels.
• Oversee the performance of Air Handling Units (AHUs), terminal HEPA filters, LAF units, and pressure cascade systems.

GMP Compliance & Regulatory Readiness

• Ensure all HVAC activities meet cGMP, EU GMP Annex 1, FDA 21 CFR, and WHO requirements for sterile facilities.
• Lead or support HVAC-related readiness and responses during internal and external audits (USFDA, EMA, MHRA, etc.).
• Ensure HVAC systems are validated and remain in a qualified state through DQ, IQ, OQ, and PQ processes.

System Monitoring & Problem Resolution

• Monitor and analyze Building Management System (BMS) trends and Environmental Monitoring System (EMS) data to ensure continuous compliance.
• Lead root cause analysis and implement corrective and preventive actions (CAPA) for any deviations or HVAC-related environmental excursions.

Project & Engineering Support

• Provide expert input in the design and installation of new HVAC systems in sterile areas.
• Review technical drawings (P&IDs, HVAC layouts), control logic, equipment specifications, and commissioning documents.
• Coordinate HVAC activities during shutdowns, cleanroom refurbishments, or qualification campaigns.

SOPs & Documentation

• Develop, review, and enforce SOPs, work instructions, and maintenance plans for sterile HVAC systems.
• Ensure timely and accurate documentation of maintenance, calibrations, deviations, and changes via GMP-compliant systems.

Qualifications and Experience:

• Bachelor's degree in Mechanical Engineering, HVAC Engineering, or a related field.
• Minimum 7+ years of progressive experience in pharmaceutical HVAC systems, with at least 5 years in a leadership role focused on sterile/Aseptic manufacturing.
• Expertise in managing cleanroom environments (Grade A to D) and HVAC systems designed for sterile operations.
• Strong experience with terminal HEPA filtration, BMS integration, airflow visualization, and HVAC qualification protocols.

Key Competencies:

• Deep understanding of GMP, EU GMP Annex 1, ISO 14644, and sterile manufacturing environmental controls.
• Proven leadership skills, with the ability to manage cross-functional HVAC teams in high-pressure, regulated environments.
• Strong troubleshooting and root cause analysis capability related to HVAC systems and environmental control.
• Excellent communication, organizational, and decision-making skills.

Preferred Certifications & Tools:

• Certified in cleanroom/HVAC design, operation, or GMP compliance (e.g., PDA, ISPE, CIBSE).
• Hands-on experience with Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and HVAC balancing tools.
• Familiarity with energy optimization and HVAC performance monitoring tools.