Subject Matter Expert/Specialist-HVAC

Job Summary

Job Location - Gurgaon, Kolkata, Ahmedabad, Chennai, Hyderabad, Bengaluru & Pune.

The HVAC Subject Matter Expert (SME) provides strategic and technical leadership in the design, validation, and operation of HVAC systems for pharmaceutical manufacturing facilities. This role ensures compliance with global regulatory standards (cGMP, WHO, USFDA, EU-GMP) and supports cross-functional teams in delivering robust, compliant, and energy-efficient HVAC solutions. The SME is recognized as an expert with deep, specialized knowledge of HVAC systems, providing technical leadership for complex design, operation, and maintenance projects. His role involves high-level strategic planning, problem-solving, and quality assurance, within the organization, contributing to functional strategy, solving complex problems, and leading initiatives that have a broad impact on business operations. Manage the activity as assigned by Group Lead / DM.

HVAC Technical Expertise & Design Leadership

1. Serve as the go-to expert for all HVAC-related technical matters.
2. Act as a strategic advisor to senior leadership on HVAC-related infrastructure planning, risk mitigation, and regulatory readiness.
3. Recognized as an expert within the company with in-depth expertise in HVAC and broad knowledge of related disciplines (e.g., automation, quality, validation).
4. Serve as the subject matter expert for all HVAC-related technical matters across pharmaceutical projects.
5. Lead HVAC system design and engineering, ensuring compliance with ASHRAE, ISHRAE, NBC, EU GMP Annex 1, USFDA 21 CFR Part 11, WHO, ISPE, and ISO 14644.
6. Design and validate HVAC systems for sterile and non-sterile pharmaceutical manufacturing areas, including cleanroom classification, pressure cascade zoning, and HEPA filtration.
7. Review and validate complete HVAC design packages including heat load calculations, AHU zoning, pressure zoning, and equipment selection.
8. Perform CFD analysis and energy modelling to optimize airflow, thermal zoning, and system efficiency.
9. Develop and maintain HVAC design standards, specifications, and best practices across regulated environments.

Project & Performance Management

1. Lead HVAC project execution across pharmaceutical facilities, managing timelines, budgets, and multidisciplinary resources.
2. Oversee HVAC scope definition, procurement strategy, and contractor coordination to ensure timely and cost-effective delivery.
3. Conduct risk assessments and implement mitigation plans for HVAC-related project risks including compliance delays and equipment failures.
4. Coordinate with cross-functional teams to ensure HVAC deliverables align with overall facility design and operational goals.
5. Establish KPIs and dashboards to monitor HVAC system reliability, compliance, uptime, and energy efficiency across multiple sites.
6. Implement performance tracking systems for HVAC assets using CMMS and BMS/EMS integrations.
7. Lead commissioning and qualification activities, ensuring HVAC systems meet design intent and regulatory requirements.
8. Manage change control processes for HVAC scope modifications, ensuring documentation and validation are updated accordingly.
9. Conduct post-project reviews and lessons-learned sessions to drive continuous improvement in HVAC project execution.
10. Maintain comprehensive project documentation including meeting minutes, hold lists, comment logs, assumption registers, and technical clarifications.

Regulatory Compliance & External Representation

1. Ensure HVAC systems meet global regulatory standards and inspection readiness criteria.
2. Prepare and review HVAC validation protocols (DQ, IQ, OQ, PQ), risk assessments, and change control documentation.
3. Represent the organization in regulatory audits, external forums, and industry working groups.
4. Develop internal HVAC audit frameworks and conduct periodic gap assessments for GMP and Pharmaceuticals standards.
5. Anticipates internal and external business challenges, vendor and regulatory issues, and recommends improvements to processes, products, or services.