What are the responsibilities and job description for the Facilities/Utilities SME position at Piper Companies?
Piper Companies is seeking a BioPharma Facilities/Utilities 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 provide technical expertise and strategic guidance for all utility systems—both clean and plant—throughout the design, construction, and commissioning of our new GMP manufacturing facility. This role is critical to ensuring that all systems are designed and executed to meet regulatory standards, operational efficiency, and long-term reliability.
Responsibilities include:
- Serve as the lead technical expert on facility utilities including HVAC, chilled water, steam, compressed air, WFI, clean steam, RO/DI water, and other critical systems.
- Collaborate with design and engineering partners to review utility system designs, specifications, and layouts for compliance with industry and regulatory standards.
- Support procurement, installation, and commissioning of utility equipment and systems.
- Partner with construction, validation, quality, and operations teams to ensure seamless integration and startup of utilities into GMP operations.
- Oversee utility performance testing, FAT/SAT protocols, and qualification documentation.
- Identify and mitigate technical risks, ensuring robust and sustainable system performance.
- Provide input into facility master planning, preventative maintenance programs, and long-term asset management strategies.
- Ensure adherence to cGMP, FDA, ASME, ISPE, and other applicable standards and guidelines.
Qualifications include:
- Bachelor’s degree in mechanical engineering, Facilities Engineering, or related discipline; advanced degree or certifications (e.g., PE, CEM, LEED) are a plus.
- 7 years of experience in facility/utility systems design, operation, or project execution in pharmaceutical, biotech, or GMP-regulated environments.
- Deep understanding of clean utility systems, HVAC design for controlled environments, and regulatory compliance for pharmaceutical facilities.
- Proven experience supporting large-scale capital projects through construction and operational startup.
- Strong project coordination, analytical, and troubleshooting skills.
- Effective communicator with the ability to work cross-functionally in a fast-paced, team-oriented environment.
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 4/15/2025. Applications for this job will be accepted for at least 30 days from the posting date.
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