Participate in and lead technical sessions related to HVAC and building mechanical system engineering and design.
Develop practical, innovative solutions to HVAC and building mechanical engineering challenges.
Coordinate and support vendor startup and execution activities, including Site Acceptance Testing (SAT).
Lead and support startup activities for plant utilities, including: Black Utilities (chilled water, plant steam) Clean Utilities (WFI, Clean Steam) Waste and air systems.
Execute the full Commissioning and Qualification (C&Q) lifecycle for utility and facility systems, including the development and execution of IQ/OQ/PQ protocols.
Bridge engineering, commissioning, and validation activities by supporting the transition from vendor startup and construction to formal commissioning and qualification.
Perform field walk-downs and P&ID redlining to ensure “as-built” accuracy during the transition from construction to validation.
Ensure HVAC, mechanical, and utility systems comply with current Good Manufacturing Practices (cGMP).
Develop, review, and maintain technical documentation, including SOPs, requirements specifications, testing protocols, summary reports, and field turnover packages.
Collaborate with cross-functional client teams to lead and support project initiatives, plans, and workstreams, ensuring high-quality and timely deliverables.

Bachelor’s Degree in Life Science, Engineering, or a related discipline, or an equivalent combination of education and relevant work experience.
Minimum of 5+ years of experience as a Project Engineer, Consultant, or in a related engineering role.
Hands-on experience supporting HVAC, utilities engineering, and/or cGMP facility startups.
Experience working in regulated manufacturing environments.
Ability to work full-time on-site at client locations.
Willingness to travel as required to support project and business needs.
Demonstrated consultative flexibility, with the ability to pivot from high-level utility design to hands-on equipment qualification and field-side troubleshooting.
Experience with a broad range of utilities, including both: Black Utilities (chilled water, plant steam) Clean Utilities (WFI, Clean Steam).
Experience in the design, installation, and qualification of cGMP HVAC systems supporting classified spaces including cascading pressure; filtered, single pass and monitored.
Familiarity with ASTM E2500 and/or ISPE Baseline Guides for Commissioning and Qualification.
Strong attention to detail, particularly in field execution and documentation accuracy.
High degree of technical competence, problem-solving ability, and adaptability in fast-paced project environments.

Fill/Finish Process Engineer

Key skills