Job Summary:
The HVAC Engineer is responsible for the design, implementation, validation, and maintenance of HVAC systems in cleanroom and controlled environments used for manufacturing fluid handling components such as pumps, valves, tubing, and hoses in the biopharma industry. This role ensures that temperature, humidity, air change rates, and particulate control are in compliance with regulatory standards, enabling contamination-free production in classified areas.
Key Responsibilities:
HVAC Design & Implementation:
Design and specify HVAC systems for cleanrooms and GMP-controlled manufacturing areas.
Ensure optimal air flow, temperature, humidity, pressure differentials, and HEPA filtration in line with ISO 14644, cGMP, and ASHRAE guidelines.
Support facility layout planning for cleanroom zoning, material/personnel flow, and HVAC zoning to reduce cross-contamination risks.
Select and size air handling units (AHUs), chillers, dehumidifiers, and terminal HEPA units based on cleanroom class and fluid handling equipment specifications.
Cleanroom & Environmental Control:
Ensure classified areas (ISO 5, ISO 7, ISO 8) maintain validated environmental conditions.
Monitor and control HVAC parameters critical to bioprocessing operations including pressure cascades, temperature uniformity, and air change rates.
Validate cleanroom HVAC systems as per IQ/OQ/PQ protocols.
Project Execution & Coordination:
Collaborate with cross-functional teams (process, production, QA, and maintenance) during new facility projects or system upgrades.
Review and approve HVAC-related P&IDs, drawings, BOQs, and design documentation.
Coordinate with vendors and contractors for HVAC installation, commissioning, and testing.
Maintenance & Compliance:
Develop and oversee preventive and corrective maintenance schedules for HVAC equipment.
Lead HVAC system troubleshooting to minimize downtime and contamination risks.
Maintain HVAC documentation, calibration logs, and environmental monitoring records.
Ensure systems are audit-ready and compliant with FDA, EU GMP, and WHO GMP requirements.
Energy Management & Efficiency:
Monitor HVAC energy consumption and suggest energy-efficient upgrades.
Support implementation of Building Management Systems (BMS) and control strategies to optimize HVAC performance.
Qualifications & Experience:
Bachelor’s Degree and Diploma Mechanical Engineering, HVAC Engineering, or related field.
3–8 years of experience in HVAC design, operation, or maintenance in biopharma, life sciences, or cleanroom-intensive manufacturing environments.
In-depth understanding of cleanroom HVAC systems, GMP, ISO 14644 standards, and aseptic design principles.
Key Skills:
Strong knowledge of HVAC system design for cleanrooms and controlled environments.
Familiarity with biopharma production processes, especially those involving sterile fluid handling systems.
Proficient in AutoCAD, Revit MEP, and HVAC calculation tools (e.g., HAP, Trace).
Understanding of airflow visualization studies (smoke tests), DQ/IQ/OQ/PQ, and risk-based approaches to HVAC validation.
Excellent documentation, troubleshooting, and cross-functional collaboration skills.
Job Types: Full-time, Permanent
Pay: ₹35,000.00 - ₹45,000.00 per month
Benefits:
Work Location: In person
