Sr. Principal Process Engineer –Packaging

jj; Charlotte (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson in Wilson, North Carolina seeks a Sr. Principal Process Engineer – Packaging to own end-to-end packaging in biotherapeutic manufacturing.

You will lead design, qualification, and startup activities for aseptic packaging equipment across the product lifecycle, partnering with cross-functional teams and external vendors to drive compliant, high-quality solutions. The role requires a strong background in large-molecule biotherapeutics, capital projects, and cGMPs, with travel and

Qualifications

• Bachelor’s degree in engineering required; mechanical preferred.
• MS or MBA preferred.
• 10+ years packaging equipment process engineering in biotherapeutics or large-molecule environments.
• Experience leading packaging equipment process engineering activities across the full product lifecycle.
• Strong background in aseptic packaging equipment principles and regulatory expectations.
• Ability to lead remote and multicultural teams and collaborate with external partners.

Responsibilities

• Lead packaging specifications and drawings (URS, data sheets, P&IDs, PFDs) for large-molecule operations.
• Provide process system ownership for packaging equipment in manufacturing.
• Assess vendor capabilities, review bid documents, manage deployment and system performance.
• Lead design and development of packaging equipment with multi-functional teams and vendors.
• Serve as Packaging Equipment SME for biotherapeutic projects with external partners.
• Lead FAT, SAT, commissioning, qualification and startup activities.
• Resolve complex technical issues during C&Q and readiness for qualification.
• Align priorities with Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS, and EHS.
• Maintain knowledge of industry trends and regulatory expectations.

Skills

Packaging engineering

Capital projects

Biotherapeutics packaging

Cross-functional collaboration

Regulatory compliance (cGMP)

Serialization & aggregation

Problem solving

Vendor management

Education

Bachelor's in engineering

MS or MBA preferred

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

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