Purpose

To ensure routine 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 manufacturing operations.

Position / Job Title Senior Technician/Fitter – HVAC Systems

Department Engineering

Reporting To Assistant Manager, Engineering

Location Pithampur

Years of Experience 5–8 Years of relevant experience in reputed OSD and/or Injectable

Pharmaceutical Manufacturing Facilities

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: without dependency on third-party manpower.

Pre-filter cleaning

Fine filter replacement

Filter differential pressure monitoring

Utility Systems Operation: Candidate should possess working knowledge of:

Chiller System, Cooling Tower System & Air Compressor System

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.

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.

Qualifications

Qualification & Experience

Regular ITI/Diploma (Fitter/Mechanical/Refrigeration & Air Conditioning)

Additional Notes

Skills & Competencies

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