Senior Technician III

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