Principal Process Engineer– Device Assembly (DA)

Johnson & Johnson Innovative Medicine; Wilson (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Wilson, NC seeks a Senior Device Assembly Process Engineer to lead design, development, and deployment of aseptic device assembly equipment for large-molecule biotherapeutics.

The role requires 7+ years of experience in cGMP environments, cross-functional collaboration, and ensuring regulatory compliance. On-site with high travel until startup, offering a competitive package.

Qualifications

• A minimum of 7 years device assembly equipment process engineering and/or device assembly capital project execution experience within a large-molecule, biotherapeutic cGMP environment.
• Strong background in aseptic, large-molecule, biotherapeutic drug product device assembly principles.
• Experience leading device assembly process engineering activities across the full product lifecycle, preferably within capital project execution.
• Shown ability to build and maintain positive relationships with multi-functional partners.
• Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design of device assembly equipment for large-molecule, biotherapeutic products

Responsibilities

• Leads development and delivery of device assembly 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 aseptic device assembly 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 aseptic device assembly equipment, collaborating with multi-functional partners and strategic equipment vendors
• Serve as the Device Assembly 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 full compliance with company policies, cGMPs, regulatory requirements, and customer specifications

Skills

Agile Decision Making

Corrective and Preventive Action (CAPA

Process Engineering

Device Assembly

Multi-functional Collaboration

Lean Supply Chain

Industrial Hygiene

Technical Research

Organizing

Program Management

Education

Bachelor's degree in engineering

MS or MBA

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

Key Responsibilities

• Leads development and delivery of device assembly 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 aseptic device assembly 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 aseptic device assembly equipment, collaborating with multi-functional partners and strategic equipment vendors
• Serve as the Device Assembly 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 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 7 years device assembly equipment process engineering and/or device assembly capital project execution experience within a large-molecule, biotherapeutic cGMP environment
• Strong background in aseptic, large-molecule, biotherapeutic drug product device assembly principles
• Experience leading device assembly process engineering activities across the full product lifecycle, preferably within capital project execution
• Shown ability to build and maintain positive relationships with multi-functional partners
• Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design of device assembly equipment for large-molecule, biotherapeutic products

Solid Understanding Of The Following

• cGMP requirements for aseptic device assembly equipment
• 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 device assembly 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 in device assembly equipment

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

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 under 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, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research