Principal Process Engineer– Device Assembly (DA)

Johnson & Johnson•Wilson, NC

1d•Onsite

About The Position

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. 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.

Requirements

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 cGMP requirements for aseptic device assembly equipment
Solid understanding of EHS requirements, with emphasis on EHS-by-design and construction safety
Solid understanding of Start-up processes and Commissioning & Qualification (C&Q) of aseptic equipment
Solid understanding of Engineering design principles for biotherapeutic drug product manufacturing
Solid understanding of 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

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

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