Sr. Principal Process Engineer -Packaging

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Supply Chain Engineering

Process Engineering

Scientific/Technology

Wilson, North Carolina, United States of America

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

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

• Leads development and delivery of packaging specifications and drawings (user requirements, data sheets, technical specifications, PIDs, PFDs) supporting large-molecule, aseptic biotherapeutic drug product operations
• Provide process system ownership and technical leadership for packaging 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 packaging equipment for biotherapeutic drug products, collaborating with multi-functional partners and strategic equipment vendors
• Serve as the Packaging 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 alignment across evolving business needs, applying strong collaborator and partner leadership skills
• Maintain current knowledge of industry trends, aseptic processing techniques, 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

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

• A minimum of 10 years packaging equipment process engineering and/or capital project execution experience within a large-molecule, biotherapeutic and synthetics environment
• Strong background in large-molecule, biotherapeutic drug product device packaging equipment principles
• Experience leading packaging equipment process engineering activities across the full product lifecycle, preferably within capital project execution
• Shown ability to build and maintain strong partnerships with multi-functional customers
• Ability to lead and influence multicultural teams and remote collaborators
• Extensive interaction with external partners (A&E firms, construction teams, and equipment vendors) as Packaging Equipment SME
• Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design of packaging equipment for large-molecule, biotherapeutic products
• Significant experience with implementing serialization and aggregation for the packaging of large-molecule, biotherapeutic products

• cGMP requirements for biotherapeutic, large-molecule packaging equipment
• Serialization and aggregation processes for finished biotherapeutic drug products
• 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 driving innovation in aseptic equipment and facility design

• Demonstrated leadership of capital projects for aseptic…