We are seeking an experienced and technically skilled Facility HVAC Manager – Clean Zones and Cold Rooms to lead the operations, maintenance, and performance of environmental control systems in regulated and temperature-sensitive areas. This includes managing HVAC systems serving ISO-classified cleanrooms, GMP manufacturing zones, and temperature-controlled cold storage areas (e.g., 2–8°C, -20°C, -80°C).
The ideal candidate will have deep expertise in HVAC systems design and maintenance for validated environments, and a strong understanding of regulatory compliance, air balance, HEPA filtration, and environmental monitoring.
Oversee the operation and maintenance of HVAC systems serving cleanrooms, cold rooms, and production suites.
Maintain air quality standards (temperature, humidity, pressure differentials, particulate counts) per ISO, GMP, and/or client standards.
Ensure optimal performance of AHUs, chillers, dehumidifiers, HEPA filters, VAVs, and control systems.
Support validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for HVAC systems.
Ensure environmental systems comply with relevant regulations (e.g., FDA, EU GMP Annex 1, ISO 14644, USP <797>/<800>).
Coordinate with Quality, EHS, and Compliance teams to ensure audit readiness at all times.
Manage temperature-controlled storage environments (2–8°C, -20°C, -80°C, cryogenic rooms) and ensure validated stability.
Monitor temperature and humidity via building automation systems (BMS) and alarm/alert protocols.
Perform root cause investigations and CAPAs in response to excursions or equipment failures.
Lead preventive and predictive maintenance activities on HVAC and refrigeration systems.
Manage CMMS (Computerized Maintenance Management System) scheduling, work orders, and reporting.
Maintain system uptime and minimize disruptions to critical environments.
Support design, installation, and commissioning of HVAC and cold chain infrastructure for facility expansions or retrofits.
Work with internal project teams and external vendors to implement upgrades or modifications.
Supervise HVAC technicians, contractors, and service providers.
Develop SOPs and provide training on cleanroom practices, HVAC operation, and emergency response protocols.
Cleanroom Airflow & Filtration - Maintain ISO classifications, pressure differentials, and HEPA filter integrity.
Cold Chain Temperature Stability - Ensure consistent performance of cold rooms and ultra-low storage environments.
Regulatory Compliance - Meet GMP, ISO, and validation standards for controlled environments.
Alarm & Monitoring Systems - Ensure continuous environmental monitoring and timely response to deviations.
Preventive Maintenance - Minimize downtime through scheduled maintenance and proactive equipment care.
Root Cause & CAPA Management - Lead HVAC investigations and corrective actions for environmental excursions.
Education:
Bachelor’s degree in Mechanical Engineering, HVAC Technology, or related field (or equivalent experience).
Relevant certifications (e.g., CFC license, HVACR certification, NEBB, TAB, or CETA) are a plus.
Experience:
7+ years in HVAC systems management, with at least 3 years in GMP, pharmaceutical, biotech, or clean manufacturing environments.
Hands-on experience with BMS, environmental monitoring, and validated systems.
Technical Skills:
In-depth knowledge of cleanroom standards (ISO 14644), air changes per hour (ACH), and HEPA filtration systems.
Experience with refrigeration systems (walk-ins, ultra-low freezers), ductwork, airflow testing (TAB), and pressure mapping.
Proficiency in CMMS and BMS (e.g., Siemens, Honeywell, Johnson Controls).
Technical troubleshooting and problem-solving
Strong attention to detail in regulated environments
Knowledge of GMP documentation and deviation handling
Team leadership and contractor/vendor coordination
Communication and cross-functional collaboration