Sr. Principal Process Engineer – Packaging

Key Responsibilities

• Leads development and delivery of packaging 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 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

Qualifications

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

Experience and Skills

Required: 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
• Solid understanding of cGMP requirements for biotherapeutic, large-molecule packaging equipment
• Solid understanding of serialization and aggregation processes for finished biotherapeutic drug products
• Solid understanding of EHS requirements, with emphasis on EHS-by-design and construction safety
• Solid understanding of start-up processes and Commissioning & Qualification (C&Q) of aseptic equipment
• Solid understanding of engineering design principles for biotherapeutic drug product manufacturing
• Solid understanding of 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

Preferred

• Demonstrated leadership of capital projects for aseptic large-molecule, biotherapeutic packaging equipment in the $50-$100 MM range
• 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 for packaging equipment
• Experience with combination products and associated regulatory expectations
• Experience with automated case packers and automated palletizers

This position will be 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.