Learn more and apply to this exciting new role!
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.
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 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
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
Other
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills
Preferred Skills
Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Technical Research
