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Purpose

HVAC Operator - To ensure efficient operation, maintenance,

compliance, and reliability of HVAC and utility systems in accordance with cGMP, Data Integrity (ALCOA+), Quality Management Systems

(QMS), and engineering best practices, while maintaining the environmental conditions required for pharmaceutical manufacturing operations.

Position / Job Title

Shift Technician/Fitter – HVAC & Utilities

Department

Engineering – Utilities & HVAC

Reporting To

Assistant Manager, Engineering

Location

Pithampur

Years of Experience

6–9 Years of relevant experience in reputed OSD and/or Injectable

Pharmaceutical Manufacturing Facilities

Candidate must be on the direct payroll of a reputed pharmaceutical organization

Profiles from contract manpower agencies, facility management companies, or third-party contractual firms shall not be considered

Dosage Form

Solid & Semi solid

Job Responsibilities /Deliverables

HVAC System Operation & Maintenance

Operate and maintain HVAC systems serving manufacturing,

packing, warehouse, dispensing, QC, Microbiology, utility, and ancillary areas.

Monitor and maintain critical environmental parameters,

including:

Differential Pressure (DP)

Temperature

Relative Humidity (%RH)

Air Changes per Hour (ACH)

Ensure uninterrupted operation of:

AHUs

Exhaust Systems

Fresh Air Systems

Dehumidification Systems

Ventilation Systems

Perform routine inspection and troubleshooting of HVAC equipment.

Maintain HVAC equipment in a validated and compliant state.

Preventive Maintenance & Calibration

Execute preventive maintenance activities as per approved PM planner.

Coordinate and support calibration of HVAC instruments,

including:

Differential Pressure Sensors

Temperature Sensors

RH Sensors

Air Velocity and Airflow Measuring Instruments

Ensure timely closure of PM and calibration activities.

Maintain maintenance records and calibration documentation.





Qualification & Validation Support

Execute and support: IQ, OQ & PQ as per departmental requirements and supervisor instructions.

Support HVAC qualification activities including:

Airflow Visualization (Smoke Studies)

Recovery Studies

Air Velocity Measurement

HEPA Filter Integrity Testing

Room Pressure Verification

Temperature & RH Mapping

Coordinate with third-party qualification agencies during validation activities.

Seasonal Mapping Activities

Participate in for manufacturing and storage areas.

Coordinate with external agencies for mapping studies.

Review and maintain associated qualification records.

Filter Maintenance

Perform filter inspection, cleaning, replacement, and integrity verification.

Independently execute

Pre-filter cleaning

Fine filter replacement

Filter differential pressure monitoring without dependency on third-party manpower.

Utility Systems Operation

Candidate should possess working knowledge of:

Chiller System

Water-cooled chillers

Chilled water pumps

Expansion tanks

Air separators

Cooling Tower System

Cooling tower operation

Water treatment coordination

Cooling tower maintenance and monitoring

Air Compressor System

Air compressor operation

Air receiver maintenance

Compressed air distribution system monitoring

GMP & QMS Compliance

Follow cGMP requirements at all times.

Ensure compliance with: Maintain

Equipment Logbooks

Utility Logbooks

PM Records

Calibration Records

Breakdown Records

Participate in:

Deviation Investigations

CAPA Activities

Change Control Activities





Internal Audits

Regulatory Audits

Housekeeping & Safety

Maintain HVAC service floors and utility areas in a clean and organized condition.

Ensure:

Good housekeeping standards

Proper lighting arrangements

Safe access to HVAC equipment

Compliance with EHS requirements

Monitor proper functioning of:

Access Control System (ACS)

Utility area infrastructure

Service floor utilities

Documentation & GMP Compliance

Record all maintenance activities in logbooks, PM sheets, and job cards as per GDP.

Follow ALCOA+ principles for maintenance documentation.

Support audits (QA, EHS, regulatory) with accurate and updated records.

Report deviations, breakages, abnormalities, and support CAPA closure.

Support engineering documentation: logbooks, PM checklists,

calibration coordination.

Installation & Commissioning

Assist in installation and commissioning of new equipment in existing/new facility.

Safety & Compliance

Follow Permit to Work (PTW), Lockout-Tagout (LOTO) and utility safety protocols.

Ensure proper use of PPE and adherence to plant safety standards.

Support EHS inspections and implement corrective actions.

Qualification & Experience

Regular ITI (Fitter/Mechanical/Refrigeration & Air

Conditioning) or Diploma in Mechanical Engineering

Full time regular course only

Additional notes Skills & Competencies

Mandatory

HVAC Operation & Maintenance

AHU Performance Monitoring

Chiller Operation

Cooling Tower Operation

Air Compressor Operation

HVAC Qualification Activities

Preventive Maintenance Planning

Instrument Calibration Support

GMP Compliance

ALCOA+ Compliance

Documentation Practices

Key Performance Indicators (KPIs)

Zero Quality Incidents

100% adherence of PM Schedular

100% calibration schedular

Utility Equipment uptime score must be more than 85%

Zero Safety Incidents

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