Fill​/Finish Process Engineer

Responsibilities

• 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& 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 work streams, 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.