Job Summary
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
Recognized as an expert within the company with in-depth expertise in HVAC and broad knowledge of related disciplines (e.g., automation, quality, validation).
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.
Design and validate HVAC systems for sterile and non-sterile pharmaceutical manufacturing areas, including cleanroom classification, pressure cascade zoning, and HEPA filtration.
Review and validate complete HVAC design packages including heat load calculations, AHU zoning, pressure zoning, and equipment selection.
Project & Performance Management
Lead HVAC project execution across pharmaceutical facilities, managing timelines, budgets, and multidisciplinary resources.
Establish KPIs and dashboards to monitor HVAC system reliability, compliance, uptime, and energy efficiency across multiple sites.
Maintain comprehensive project documentation including meeting minutes, hold lists, comment logs, assumption registers, and technical clarifications.
Regulatory Compliance & External Representation
Prepare and review HVAC validation protocols (DQ, IQ, OQ, PQ), risk assessments, and change control documentation.
Anticipates internal and external business challenges, vendor and regulatory issues, and recommends improvements to processes, products, or services.