Team Leader - HVAC

Position Overview

The role calls for leading and managing a team of engineers and technicians focused on the operation, upkeep, and ongoing enhancement of HVAC systems within sterile pharmaceutical manufacturing environments. Critical responsibilities include maintaining environmental controls, ensuring compliance with regulatory standards, and guaranteeing the reliability of HVAC systems in cleanroom and aseptic processing facilities.

Key Duties

• Oversee and coordinate daily operations of the HVAC team to maintain optimal performance in sterile and aseptic production zones.
• Allocate and prioritize tasks related to preventive, corrective, and predictive maintenance activities for HVAC equipment.
• Provide mentorship, training, and performance evaluation for HVAC technicians and junior engineers, promoting high levels of technical expertise and compliance.
• Maintain strict environmental conditions in cleanrooms (Grades A to D), monitoring parameters such as temperature, humidity, differential pressure, airflow direction, and particulate counts.
• Supervise the efficiency and operation of Air Handling Units (AHUs), terminal HEPA filters, Laminar Air Flow units, and pressure cascade arrangements.
• Ensure all HVAC operations comply with cGMP, EU GMP Annex 1, FDA 21 CFR, WHO, and other relevant regulations for sterile manufacturing setups.
• Lead or assist in preparation and response for internal and external audits by regulatory bodies including USFDA, EMA, and MHRA.
• Manage HVAC system validation and qualification processes including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Monitor Building Management System (BMS) data and Environmental Monitoring System (EMS) outputs to maintain continuous compliance and detect deviations.
• Conduct root cause analysis and implement corrective and preventive measures (CAPA) to address any HVAC or environmental control issues.
• Contribute expertise to the design, installation, and commissioning of new HVAC systems tailored for sterile areas.
• Review technical documentation including Piping and Instrumentation Diagrams (P&IDs), HVAC layouts, control logics, equipment specifications, and commissioning reports.
• Coordinate HVAC-related activities during facility shutdowns, cleanroom refurbishments, and equipment qualification initiatives.
• Develop and supervise adherence to Standard Operating Procedures (SOPs), work instructions, and maintenance schedules for HVAC systems in sterile environments.
• Maintain GMP-compliant records related to maintenance activities, calibrations, deviations, and system changes.

Qualifications and Experience

• A Bachelor's degree in Mechanical Engineering, HVAC Engineering, or a related discipline.
• At least 7 years of progressively responsible experience managing pharmaceutical HVAC systems.
• Thorough knowledge and experience in managing cleanroom environments, ranging from Grade A to D, within sterile operating contexts.
• Expertise working with terminal HEPA filters, integration of BMS, airflow pattern visualization, and HVAC qualification protocols.

Core Competencies

• Comprehensive understanding of GMP, EU GMP Annex 1, ISO 14644, and environmental control standards in sterile manufacturing.
• Proven ability to lead multidisciplinary HVAC teams under stringent regulatory and high-pressure conditions.
• Strong skills in troubleshooting, root cause diagnosis, and resolution related to HVAC system performance.
• Excellent communication, organizational, and sound decision-making capabilities.

Preferred Certifications and Technical Skills

• Certification in cleanroom/HVAC design, operational excellence, or GMP compliance from recognized bodies such as PDA, ISPE, or CIBSE.
• Practical experience with Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and HVAC balancing instruments.
• Understanding of energy optimization techniques and the use of HVAC performance monitoring tools.