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About Innovative Medicine

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Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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As part of the Global Process Engineering team, the Principal Engineer Process Engineer serves as the recognized technical authority and Subject Matter Expert for logistics. This role is accountable for end00 (E2E) process engineering ownership of the logistics design. The role is responsible for definition of warehouse equipment including warehouse type (conventional, ASRS, etc.) and material handling equipment including robotic movement, material flows, and collaboration with automation and inventory management teams.

Key Responsibilities:

• Lead development and delivery of the logistics area, including specifications and drawings (URS, data sheets, technical specifications, P&IDs, PFDs) supporting large00, 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 cross00functional partners and strategic equipment vendors

• Serve as the logistics Subject Matter Expert (SME) for large00, 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 start00 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 data00driven 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 Bachelor00 degree in Engineering required

• Master00 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 cross00functional 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 EHS00by00design and construction safety

• Start00up 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, problem00solving capability, communication skills, and decision00making ability in a fast00paced 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 large00molecule biotherapeutic drug product environments

• Experience supporting greenfield or brownfield GMP aseptic manufacturing facility start00ups 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.

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