Sr. Principal Process Engineer –Packaging
Johnson & Johnson Innovative Medicine•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.
Requirements
- A minimum Bachelor's Degree in engineering required (Mechanical Engineering 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
- 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
- MS or MBA 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
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Principal
