We are seeking a highly experienced and technically proficient Senior HVAC Design Engineer to lead the planning, design, and execution of HVAC systems for GMP-compliant and ISO-classified cleanroom environments. This role is critical in ensuring that environmental control systems meet stringent regulatory and quality requirements for temperature, humidity, pressure differentials, and particulate control.
The ideal candidate will have a strong background in HVAC design for pharmaceutical, biotech, life sciences, or semiconductor facilities, along with a thorough understanding of cleanroom classification, FDA/EU GMP regulations, and ISO 14644 standards.
Lead HVAC system design for GMP facilities, cleanrooms (ISO 5–8), aseptic suites, laboratories, and high-containment spaces.
Perform advanced HVAC calculations, including heat loads, pressure differentials, air change rates, and psychrometrics.
Develop and oversee the creation of design documentation such as system schematics, layout drawings (AutoCAD/Revit), P&IDs, and control sequences.
Ensure compliance with regulatory standards, including FDA cGMP, EU GMP, ISO 14644, ASHRAE, and ISPE Baseline Guides.
Provide technical oversight on HVAC equipment selection, duct and piping design, and cleanroom airflow distribution strategies.
Coordinate with process, electrical, architectural, and automation teams to integrate HVAC systems with facility and production requirements.
Lead HVAC system commissioning and support validation efforts (DQ/IQ/OQ), including field inspections, TAB review, and troubleshooting.
Review and approve submittals, RFIs, and technical specifications in support of construction and procurement teams.
Mentor junior and mid-level engineers, ensuring adherence to company and industry best practices.
Interface directly with clients, regulatory bodies, and third-party reviewers as a technical SME.
GMP-Compliant HVAC Design Leadership
Ensure all HVAC systems are designed to maintain critical environmental conditions in compliance with regulatory standards.
Cleanroom Expertise
Apply deep knowledge of ISO cleanroom classifications, airflow patterns, pressure cascade strategies, and particulate control.
Technical Oversight & QA/QC
Lead technical reviews, enforce design quality, and provide guidance during design and implementation phases.
Cross-Functional Project Coordination
Integrate HVAC design with utilities, automation systems, and process requirements for full GMP compliance.
Mentorship & Thought Leadership
Guide junior engineers, support professional development, and represent the company in industry forums or technical presentations.
Bachelor’s or Master’s degree in Mechanical Engineering or a related discipline.
Minimum 7 years of experience in HVAC design, with at least 4 years in cleanroom/GMP-regulated environments.
In-depth knowledge of HVAC systems used in pharmaceutical and high-tech manufacturing, including terminal HEPA filtration, AHUs, VAV systems, and chilled water plants.
Strong familiarity with ISO 14644, cGMP regulations, EU GMP Annex 1, and ASHRAE 170/90.1.
Proficiency in design tools (Revit, AutoCAD, HAP, Trace 700) and working knowledge of BAS/BMS integration.
Excellent technical documentation and communication skills.
Ability to lead multidisciplinary teams and coordinate with clients and contractors throughout project lifecycles.
Professional Engineer (PE) License (strongly preferred)
LEED AP or Green Building Certification
Certified Cleanroom Professional (CCP)
ISPE Membership or Certification
OSHA 30 (for field/project leadership roles)