Assistant Manager, Mechanical Engineer

6 - 10 years

0 Lacs

Posted:10 hours ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Part Time

Job Description

Job Description:

We are seeking a qualified Assistant Manager – HVAC 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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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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