Principal Process Engineer - Warehouse

Key Responsibilities

• Lead development and delivery of the logistics area, including specifications and drawings (URS, data sheets, technical specifications, P&IDs, PFDs) supporting large-molecule, aseptic biotherapeutic drug product operations
• Provide process system ownership and technical leadership for logistics 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 logistics equipment, collaborating with cross-functional partners and strategic equipment vendors
• Serve as the logistics Subject Matter Expert (SME) for large-molecule, aseptic drug product projects, interfacing 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, Automation, Inventory Management, Cold Chain, and EHS to align priorities and accelerate execution
• Ensure alignment across evolving business needs, applying strong stakeholder and partner management skills
• Maintain current knowledge of industry trends and biotherapeutic regulatory expectations
• Apply data-driven insights and market intelligence to guide technical and strategic decisions
• Ensure full compliance with company policies, cGMPs, regulatory requirements, and customer specifications

Qualifications

Education: A minimum Bachelor's degree in Engineering required. Master's degree or MBA preferred.

Experience and Skills

Required: Minimum of 10 years logistics process engineering and/or capital project execution experience within a large-molecule, biotherapeutic cGMP environment. Strong experience driving floorplan design for warehouse, material transport corridors, and in-process storage areas through simulation modeling, process mapping, and time studies to maximize flow efficiency. Proven ability to build and maintain strong partnerships with cross-functional stakeholders. Ability to lead and influence multicultural teams and remote collaborators. Extensive interaction with external partners (A&E firms, construction teams, and equipment vendors) as a logistics process engineer. Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design in logistics for large-molecule, biotherapeutic products. Solid understanding of: cGMP requirements for logistics of large-molecule biotherapeutic products; EHS requirements, with emphasis on EHS-by-design and construction safety; Start-up processes and Commissioning & Qualification (C&Q) for a large-scale biotherapeutic logistics operation; Engineering design principles for biotherapeutic drug product manufacturing; Construction, procurement, project controls, and project scheduling. Strong technical depth, problem-solving capability, communication skills, and decision-making ability in a fast-paced environment. Passion for driving innovation in equipment and facility design.

Preferred: Deep process engineering expertise from conceptual design through C&Q to operational readiness in large-molecule biotherapeutic drug product environments. Experience supporting greenfield or brownfield GMP aseptic manufacturing facility start-ups in the logistics area.

Other: This position is located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson, NC.