Principal Process Engineer– Device Assembly; DA

Principal Process Engineer – Device Assembly (DA)

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 Med Tech, 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.

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

Location:

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.

As part of the Global Process Engineering team, the Principal Process Engineer – Device Assembly (DA) serves as the recognized technical authority and domain expert for device assembly equipment. This role is accountable for end-to-end (E2E) process engineering ownership of device assembly equipment, from conceptual design, commissioning and qualification, through the initial equipment start-up for commercial manufacturing.

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…