Principal Process Engineer– Device Assembly (DA)

Johnson & Johnson Innovative Medicine•Wilson, NC

3d•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. 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.

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 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

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