Sr. Principal Process Engineer –Packaging
Johnson & Johnson•Wilson, NC
•Onsite
About The Position
As part of the Global Process Engineering team, the Sr. Principal Process Engineer – Packaging serves as the recognized technical authority and domain expert for packaging equipment. This role is accountable for end-to-end (E2E) process engineering ownership of packaging equipment, from conceptual design, commissioning and qualification, through initial equipment start-up for commercial manufacturing. 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.
Requirements
- 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 the following: 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
Nice To Haves
- 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
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
Benefits
- inclusive work environment
- respect the diversity and dignity of our employees
- recognize their merit
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What This Job Offers
Job Type
Full-time
Career Level
Senior
