Team Leader - HVAC
- رأس الخيمة
- دائم
- دوام كامل
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.