with expertise in managing cleanroom and utility HVAC systems for a pharmaceutical facility. The role involves overseeing HVAC operations, maintenance, and projects while ensuring compliance with GMP, cGMP, and regulatory guidelines.
Essential Functions:
Manage and monitor HVAC systems, AHUs, chillers, cooling towers, boilers, and related utilities.
Ensure cleanroom HVAC compliance with regulatory requirements (temperature, humidity, differential pressure, filtration).
Plan and execute preventive, predictive, and breakdown maintenance of HVAC equipment.
Support installation, commissioning, qualification (IQ/OQ/PQ), and validation of HVAC systems.
Prepare and maintain SOPs, logbooks, and maintenance documentation in line with GMP standards.
Lead and supervise technicians/engineers for day-to-day operations and troubleshooting.
Coordinate with QA, Production, and Engineering teams for maintaining environmental control.
Handle vendor management, spare parts planning, and service contracts.
Drive energy conservation initiatives and efficiency improvements in HVAC utilities.
Ensure compliance during audits (USFDA, MHRA, WHO, etc.) and handle audit queries related to HVAC.
Perform risk assessments, RCA, and CAPA for deviations/failures in HVAC systems.
Monitor calibration and performance of sensors, instruments, and control systems.
Additional Responsibilities:
Develop and implement HVAC preventive maintenance schedules to minimize downtime.
Ensure compliance with statutory requirements (electrical safety, pressure vessel norms, pollution control board norms where applicable).
Coordinate with external agencies for AMC (Annual Maintenance Contracts), calibration, and service activities.
Monitor and control HVAC performance parameters through BMS/EMS and ensure data integrity.
Support change control, deviation management, and CAPA implementation for HVAC systems.
Prepare and monitor annual HVAC budget (spares, utilities, consumables, AMC costs).
Train and mentor HVAC team members on GMP, safety, and operational excellence.
Support new facility design, modifications, and HVAC validation during expansions.
Maintain availability of critical spares and ensure timely procurement.
Ensure HVAC system readiness for regulatory and customer audits at all times.
Contribute to continuous improvement and energy conservation projects.
Qualifications:
B.E./B.Tech in Mechanical Engineering (preferred)
Diploma in Mechanical Engineering with relevant HVAC specialization may also be considered
Experience:
6-10 years of experience in HVAC/utilities in
pharmaceutical
, with at least 2-3 years in a supervisory role.
Key Skills & Competencies:
Strong knowledge of cleanroom HVAC standards (ISO, EU GMP, WHO, USFDA)
Hands-on experience with AHUs, chillers, compressors, boilers, and air handling systems
Familiarity with BMS, EMS, PLC/SCADA systems preferred
Good documentation and compliance knowledge (SOPs, validation, audit handling)
* Leadership and team-handling abilities.
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