Senior HVAC Engineer

Overview

The Senior HVAC Engineer will serve as the Subject Matter Expert (SME) for HVAC systems, providing technical leadership throughout both the project and operational lifecycle. The role encompasses design, installation, commissioning, and qualification during project execution, as well as compliance, performance optimization, and continuous improvement during operations. This position ensures HVAC systems within GMP facilities are designed, validated, and operated to meet regulatory standards while safeguarding product quality, personnel safety, and energy efficiency.

Responsibilities – Design and Project Phase

• Act as HVAC SME during facility design, reviewing and approving engineering documents such as URS, FDS, P&IDs, layouts, and specifications.
• Define HVAC system design requirements for cleanrooms, controlled environments, and associated utilities, ensuring compliance with GMP and industry standards (e.g., EU Annex 1, FDA, ASHRAE, ISO, NFPA).
• Manage HVAC projects from design to completion, including URS development through issuance of RFP, scheduling and coordination with relevant stakeholders to ensure successful project delivery within scope and timelines.
• Ensure critical design elements such as pressure cascades, air change rates, filtration, and airflow patterns align with contamination control strategies.
• Participate in project meetings, design reviews, communicate project status, technical solutions, and execution of upgrade or expansion projects.
• Support HVAC system risk assessments (e.g., FMEA, HAZOP) to identify and mitigate potential compliance or reliability issues.
• Support HVAC commissioning, qualification, and validation activities, including review of protocols (IQ, OQ, PQ) and final approval of qualification reports.
• Collaborate with engineering consultants, contractors, and vendors to ensure HVAC systems are delivered on schedule, within budget, and compliant with specifications.
• Support project stakeholders by providing SME input during audits, inspections, and design reviews.
• Collaborate closely with BU/CU engineers, electrical engineers, and other stakeholders to integrate HVAC into overall facility design, ensuring seamless operation and functionality.

Operational Phase (Lifecycle, Compliance, Continuous Improvement)

• Serve as the HVAC SME for ongoing operations, ensuring systems remain in compliance with regulatory requirements and site quality standards.
• Monitor system performance through routine trending, data analysis, and advanced tools (e.g., HVAC load calculation software, CFD modelling) to ensure environmental conditions consistently meet cleanroom requirements.
• Lead troubleshooting and root cause analysis for HVAC deviations, excursions, or performance issues, and implement corrective and preventive actions.
• Maintain up-to-date knowledge of global regulations, standards, and technological advances in HVAC to ensure site readiness and continuous compliance.
• Provide technical support during audits and regulatory inspections, representing HVAC systems to regulators as SME.
• Identify and implement continuous improvement initiatives to enhance energy efficiency, system reliability, and sustainability.
• Develop and update SOPs, work instructions, and training materials related to HVAC system operation and maintenance.
• Provide training, mentoring, and technical guidance to junior engineers and operations staff, building site capability in HVAC knowledge.
• Partner with Facilities, Manufacturing, and QA teams to ensure HVAC systems are aligned with production needs, safety requirements, and environmental monitoring strategies.

Requirements

• Bachelor's degree or above in Mechanical Engineering, HVAC Engineering, or related discipline.
• Minimum of 8 years of direct HVAC engineering experience in pharmaceutical, biopharmaceutical, or cleanroom-regulated industries.
• Demonstrated expertise in HVAC design, commissioning, qualification, and lifecycle management under GMP requirements.
• Deep technical knowledge of HVAC systems for controlled environments.
• Strong familiarity with cleanroom contamination control strategies and regulatory frameworks.
• Proficiency in AutoCAD, Revit, and HVAC load calculation software; familiarity with CFD modeling is an advantage.
• Skilled in risk assessment methodologies and root cause analysis.
• Proven ability to lead cross-functional collaboration and regulatory interactions as HVAC SME.
• Self-motivated, detail-oriented, and capable of independent decision-making in complex technical matters.
• Strong communication and stakeholder management skills, with ability to explain HVAC technical concepts clearly.
• Willingness to travel domestically and internationally for project execution.
• Proficiency in the Chinese language is an advantage.

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