HVAC System Operations
- Operate and monitor HVAC systems serving manufacturing, packaging, warehouse, and laboratory areas.
- Ensure maintenance of specified temperature, humidity, differential pressure, and air change rates in classified and non-classified areas.
- Monitor HVAC system performance through BMS, EMS, and local control systems.
- Perform routine inspection of HVAC equipment and utilities.
- Ensure uninterrupted environmental conditions required for manufacturing operations.
HVAC Maintenance Activities
- Carry out preventive, predictive, corrective, and breakdown maintenance of HVAC systems.
- Maintain Air Handling Units (AHUs), Fresh Air Handling Units (FAHUs), Exhaust Systems, Chillers, Cooling Towers, and Ventilation Systems.
- Perform maintenance of motors, blowers, dampers, filters, valves, belts, and ducting systems.
- Attend HVAC breakdowns and restore systems within defined timelines.
- Support annual shutdown and maintenance activities.
Environmental Control Monitoring
- Monitor critical HVAC parameters including:
- Temperature
- Relative Humidity (RH)
- Differential Pressure
- Air Velocity
- Air Changes Per Hour (ACPH)
- Ensure environmental conditions remain within approved operating limits.
- Escalate deviations and abnormalities immediately.
- Support environmental monitoring activities in controlled manufacturing areas.
Filter Management
- Perform replacement and maintenance of pre-filters, fine filters, and HEPA filters.
- Ensure proper installation and integrity of filters.
- Support HEPA integrity testing and certification activities.
- Maintain filter replacement records and schedules.
- Coordinate with validation teams during filter qualification activities.
Utility Equipment Support
- Maintain HVAC-associated utility systems.
- Support operation and maintenance of chillers, cooling towers, pumps, compressors, and ventilation systems.
- Maintain chilled water distribution systems and air distribution networks.
- Monitor utility consumption and equipment efficiency.
- Ensure availability of HVAC utilities to production and laboratory areas.
Qualification & Validation Support
- Support HVAC qualification activities including IQ, OQ, and PQ.
- Assist in airflow visualization (smoke studies), cleanroom qualification, and requalification activities.
- Participate in HEPA filter integrity testing and recovery studies.
- Support commissioning and qualification of new HVAC systems.
- Assist in execution of change controls related to HVAC systems.
Documentation & Compliance
- Maintain HVAC operation logbooks, maintenance records, and calibration records.
- Document preventive maintenance, breakdown maintenance, and corrective actions.
- Follow Good Documentation Practices (GDP).
- Maintain equipment history records and maintenance schedules.
- Ensure compliance with Data Integrity and cGMP requirements.
cGMP & Regulatory Compliance
- Ensure HVAC systems comply with pharmaceutical regulatory requirements.
- Support readiness for USFDA, MHRA, WHO-GMP, EU-GMP, and other regulatory inspections.
- Participate in internal and external audits.
- Ensure compliance with engineering SOPs and qualification requirements.
- Support investigations related to environmental excursions and deviations.
Safety, Health & Environment (EHS)
- Follow engineering and utility safety procedures.
- Comply with Permit to Work (PTW), Lockout-Tagout (LOTO), and confined space requirements.
- Use prescribed Personal Protective Equipment (PPE).
- Report unsafe acts, unsafe conditions, and incidents.
- Participate in safety observations, risk assessments, and emergency response activities.
Spare Parts & Inventory Management
- Monitor availability of critical HVAC spares and consumables.
- Raise requests for filters, belts, motors, bearings, sensors, and spare parts.
- Ensure optimum inventory levels for uninterrupted operations.
- Support vendor coordination for material procurement and maintenance services.
Energy Management & Continuous Improvement
- Support energy conservation initiatives related to HVAC operations.
- Monitor utility consumption and identify energy-saving opportunities.
- Participate in TPM, Lean, Kaizen, and Operational Excellence initiatives.
- Suggest improvements to enhance reliability, efficiency, and compliance.
- Assist in implementation of HVAC automation and digital monitoring systems.
Team Coordination
- Coordinate with Manufacturing, QA, QC, Engineering, Validation, and Projects teams.
- Support contractors and external vendors during maintenance and qualification activities.
- Communicate equipment status and maintenance updates during shift handovers.
- Support training and development of junior team members.
Educational Qualification:
- B.Tech/B.E. in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Instrumentation Engineering, Biotechnology Engineering, or related discipline.
- Diploma in Engineering with relevant pharmaceutical utility experience may also be considered.
Experience
- 6-10 years of experience for Engineer level in pharmaceutical, biotech, vaccine, API, or regulated manufacturing industries.
- Hands-on experience in operation and maintenance of PW, WFI, Pure Steam, RO, EDI, and distribution systems preferred.
