The EVAC Engineering Officer/Executive will be responsible for the operation maintenance and continuous improvement of the HVAC (Heating Ventilation and Air Conditioning) AHU (Air Handling Units) and related utility systems supporting the OSD manufacturing facility. The role ensures compliance with cGMP regulatory and safety standards for critical environment control in drug production areas.
Key Responsibilities:
- Operate and maintain HVAC/AHU systems in compliance with cGMP and regulatory requirements (USFDA MHRA EUGMP etc.).
- Conduct preventive and breakdown maintenance of HVAC equipment air handling units dust extraction systems and exhaust systems.
- Maintain records for HVAC/AHU performance temperature RH logs and differential pressures in manufacturing areas.
- Support HVAC validation and requalification activities including DQ IQ OQ and PQ.
- Monitor and control cleanroom environmental parameters.
- Coordinate with production and QA departments for engineering support during batch production and validation.
- Troubleshoot and resolve HVAC/AHU system issues to minimize downtime.
- Ensure compliance with safety standards during maintenance activities.
- Maintain and update SOPs maintenance logs and calibration records as per regulatory expectations.
- Participate in internal and external audits and support compliance requirements.
- Contribute to energysaving initiatives and continuous improvement projects.
Qualifications & Experience:
- Diploma / B.E. / in Mechanical / Electrical / HVAC / Instrumentation Engineering.
- 25 years of relevant experience in HVAC / Utility maintenance in a regulated OSD pharmaceutical facility.
- Handson experience in AHU operation cleanroom classifications HEPA filter integrity testing and BMS systems.
- Sound knowledge of HVAC compliance as per GMP guidelines and regulatory expectations.
Key Skills:
- Good understanding of cleanroom design HVAC systems and air balancing.
- Knowledge of HVAC qualification protocols and documentation.
- Problemsolving skills with a proactive maintenance approach.
- Strong interpersonal and communication skills to coordinate with crossfunctional teams.
- Familiarity with computerized maintenance management systems (CMMS) preferred.
Required Experience:
Senior IC