Principal Process Engineer- Device Assembly (DA)

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• Leads development and delivery of device assembly specifications and drawings (user requirements, data sheets, technical specifications, P&IDs, PFDs) supporting large-molecule, aseptic biotherapeutic drug product operations

• Provide process system ownership and technical leadership for aseptic device assembly equipment used in biotherapeutic drug product manufacturing

• Assess vendor competency and capabilities, review and influence bid documents, and maintain accountability for project development and execution, including system performance

• Lead detailed design and development of aseptic device assembly equipment, collaborating with multi-functional partners and strategic equipment vendors

• Serve as the Device Assembly equipment SME for large-molecule, aseptic drug product projects, collaborating with A&E firms, construction partners, and equipment suppliers

• Lead and support equipment FAT, SAT, commissioning, qualification, and commercial production line start-up activities

• Resolve complex technical issues during C&Q and ensure system readiness for qualification and commercial operation

• Partner closely with Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS, and EHS to align priorities and accelerate execution

• Ensure full compliance with company policies, cGMPs, regulatory requirements, and customer specifications

• A minimum Bachelor's Degree in engineering required (Mechanical Engineering preferred)

• MS or MBA preferred

• A minimum of 7 years device assembly equipment process engineering and/or device assembly capital project execution experience within a large-molecule, biotherapeutic cGMP environment

• Strong background in aseptic, large-molecule, biotherapeutic drug product device assembly principles

• Experience leading device assembly process engineering activities across the full product lifecycle, preferably within capital project execution

• Shown ability to build and maintain positive relationships with multi-functional partners

• Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design of device assembly equipment for large-molecule, biotherapeutic products

• cGMP requirements for aseptic device assembly equipment

• EHS requirements, with emphasis on EHS-by-design and construction safety

• Start-up processes and Commissioning & Qualification (C&Q) of aseptic equipment

• Engineering design principles for biotherapeutic drug product manufacturing

• Construction, procurement, project controls, and project scheduling

• Strong technical depth, problem-solving capability, interpersonal skills, and decision-making ability in a fast-paced environment

• Passion for…