HVAC SME

Piper Companies is seeking a BioPharma HVAC Subject Matter Expert (SME) to join an expansion project team of a new facility build for a CDMO out in Bloomington, IN.

The role has an onsite expectation and slated through 2026 and potentially beyond. The SME will lead the implementation, and qualification of complex HVAC systems for the new GMP manufacturing facility. This role requires deep technical knowledge and hands-on experience with HVAC systems designed for cleanrooms, controlled environments, and other critical spaces in pharmaceutical or biologics manufacturing.

Responsibilities include:

• Act as the primary technical authority on HVAC systems throughout all phases of the facility buildout—from design through operational startup.
• Provide oversight and review of HVAC system design, including zoning, airflows, filtration, pressurization schemes, and temperature/humidity control.
• Ensure compliance with GMP requirements, FDA regulations, ISPE guidelines, and other relevant standards (e.g., ISO 14644, ASHRAE).
• Collaborate with cross-functional teams including design engineers, contractors, validation, QA, and operations.
• Lead or support commissioning and qualification activities (FAT/SAT/IQ/OQ) for HVAC systems and related environmental controls.
• Participate in risk assessments, design reviews, and deviation investigations.
• Support cleanroom classification, HVAC monitoring strategy development, and integration with building automation systems (BAS/BMS).
• Identify opportunities for energy efficiency, reliability, and sustainability within HVAC system designs.

Qualifications include:

• Bachelor’s degree in mechanical engineering, HVAC Engineering, or related field; PE license or relevant certifications (e.g., ASHRAE, LEED) preferred.
• 7+ years of experience with HVAC systems in pharmaceutical, biotech, or other life sciences environments.
• Strong understanding of cGMPs, cleanroom classifications, and environmental control strategies in GMP manufacturing.
• Proven experience supporting large-scale facility buildouts or renovations, ideally from concept through commissioning.
• Familiarity with automation platforms, BAS/BMS systems, and HVAC monitoring tools.
• Excellent communication, problem-solving, and collaboration skills.
• Ability to manage multiple priorities and interface with diverse internal and external stakeholders.

Compensation includes:

• Commensurate to experience
• Opportunity to influence a major facility buildout from the ground up
• Long term contract with possible extensions/conversions
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays

This job opens for applications on 4/28/2025. Applications for this job will be accepted for at least 30 days from the posting date.

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