Job Summary

• The Sr. Principal Engineer, Clean Utilities, will be the technical subject matter expert accountable for overall E2E process engineering leadership in implementing a clean utilities system into a new cGMP drug product manufacturing plant.
• Key responsibilities include developing clean utility drawings, assessing vendor capabilities, leading detailed design and development of clean utility equipment, and overseeing FAT, SAT, C&Q, and start-up.
• This role requires strong scientific, technical, and business expertise to optimize processes, solve sophisticated equipment issues, and ensure full compliance with regulatory standards.

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Skills & Requirements

Key Requirements

• Bachelor's Degree in Engineering (Mechanical preferred)
• 10+ years experience in clean utilities
• Experience in pharmaceutical, biotech, or advanced therapy manufacturing
• Understanding of cGMPs for clean utility systems
• Experience with EHS requirements
• Experience with start-up processes and C&Q

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