Role Objective To ensure effective design review, installation, commissioning, qualification, operation and maintenance of HVAC systems supporting pharmaceutical manufacturing, injectable, cleanroom, laboratory, warehouse and utility areas.

The role is responsible for maintaining required environmental conditions, GMP compliance, system reliability and audit readiness.

Desired Candidate Profile:

- B.E. Mechanical with 46 years of relevant experience in HVAC systems within pharmaceutical or regulated manufacturing environments.
- Hands-on knowledge of HVAC design review, heat-load and air-flow calculations, pressure zoning, room pressure cascade and system capacity assessment.
- Experience in operation, maintenance, troubleshooting and qualification of AHUs, blowers, pumps, filters, dampers, cooling coils, control valves, sensors and associated equipment.
- Working knowledge of cGMP documentation, preventive maintenance, calibration coordination, deviation, change control, CAPA, risk assessment and incident investigation.
- Exposure to TrackWise QMS/DMS and SAP activities such as PR, material-code creation and service entry is preferred.

Role & Responsibilities: 1. HVAC Design, Qualification & Compliance

- Review HVAC design documents, layouts, heat-load calculations, air-flow calculations, pressure zoning and system capacities.
- Review and finalize HVAC system requirements for classified and non-classified pharmaceutical areas.
- Ensure HVAC systems maintain required temperature, relative humidity, differential pressure, air changes, cleanliness classification and air filtration in accordance with GMP, regulatory and operational requirements.




- Review HVAC zoning and segregation with consideration for product containment and cross-contamination control and ensure appropriate room pressure cascades between classified areas.

2. Operation, Maintenance & Reliability

- Operate and maintain HVAC systems serving pharmaceutical manufacturing, injectable, cleanroom, laboratory, warehouse and utility areas.
- Prepare preventive-maintenance schedules for AHUs, blowers, pumps, filters, dampers, cooling coils, control valves, sensors and associated equipment.
- Ensure timely cleaning/replacement of pre-filters, fine filters and HEPA filters.
- Perform troubleshooting and root-cause analysis for HVAC breakdowns and environmental excursions, and monitor equipment performance for reliability and energy improvement.

3. GMP Documentation & Quality Systems

- Maintain engineering documentation in accordance with cGMP requirements, including equipment logbooks, preventive and breakdown maintenance records, sanitization records, daily checklists, calibration coordination records, spare-part consumption records and equipment history cards.
- Ensure activities are performed according to approved SOPs and maintain HVAC SOPs, calibration records and qualification documents.
- Raise and participate in deviations, change controls, CAPA, incident investigations and risk assessments; investigate abnormal trends and support corrective and preventive actions.
- Use TrackWise QMS and Document Management System (DMS) to support compliance with the Quality Management System.

4. Audit Readiness & SAP Support





- Maintain utility/HVAC systems in an audit-ready condition in line with applicable cGMP, WHO-GMP, Schedule M, EU-GMP and USFDA requirements.
- Use SAP for PR, material-code creation, service entry and related engineering transactions as required.

Functional Skills Required

- Pharmaceutical HVAC systems and cleanroom environmental controls.
- HVAC design review, heat-load/air-flow calculations, zoning and pressure cascade.
- Preventive and breakdown maintenance of AHUs and associated HVAC equipment.
- HEPA/pre-filter/fine-filter maintenance and environmental excursion troubleshooting.
- GMP engineering documentation, qualification, calibration coordination and audit readiness.
- QMS processes: Deviation, Change Control, CAPA, Incident Investigation and Risk Assessment.
- TrackWise QMS / DMS and basic SAP engineering transactions.

Behavioral Skills Required

- Attention to Detail: Maintains accurate engineering records and critical environmental parameters.
- Problem-Solving: Troubleshoots HVAC breakdowns and supports root-cause analysis effectively.
- Ownership & Accountability: Ensures planned maintenance, system reliability and compliance activities are completed on time.
- Communication & Coordination: Works effectively with Engineering, Production, Quality and other cross-functional teams.
- Safety & Compliance Mindset: Follows approved SOPs, GMP requirements and secure engineering practices.

Job Location

SEZ

Important Links

Website: https://biotechhealthcare.com/

LinkedIn: https://www.linkedin.com/company/biotechhealthcare/

Instagram: Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.

📌 Walk-in || Executive - HVAC System (Ahmedabad)
🏢 Biotech Vision Care
📍 Ahmedabad