Sr. Princ. Process Engineer – DP Aseptic Biotherapeutic Device Assembly and Packaging Equipment
Johnson & Johnson Innovative Medicine•Wilson, NC
•Onsite
About The Position
As part of the Global Process Engineering team, the Sr. Princ. Process Engineer serves as the recognized technical authority and Subject Matter Expert for device assembly and packaging equipment. This role is accountable for end‑to‑end (E2E) process engineering ownership of device assembly and packaging equipment, from conceptual design, commissioning and qualification, and initial equipment start-up for commercial manufacturing. 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
- Bachelor’s degree in Engineering required (Mechanical Engineering preferred)
- Minimum of 10 years device assembly and packaging process engineering and/or capital project execution experience within a large-molecule, biotherapeutic cGMP environment
- Strong background in aseptic, large-molecule, biotherapeutic drug product device assembly and packaging principles
- Experience leading device assembly and packaging process engineering activities across the full project lifecycle, preferably within capital project execution
- Proven ability to build and maintain strong partnerships with cross‑functional stakeholders
- Ability to lead and influence multicultural teams and remote collaborators
- Extensive interaction with external partners (A&E firms, construction teams, and equipment vendors) as a DAP SME
- Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design of device assembly and 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: cGMP requirements for aseptic device assembly and packaging
- Solid understanding of: Serialization and aggregation processes for finished biotherapeutic drug products
- 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, communication skills, and decision‑making ability in a fast‑paced environment
- Passion for driving innovation in aseptic equipment and facility design
Nice To Haves
- Master’s degree or MBA preferred
- Demonstrated leadership of capital projects for aseptic large-molecule, biotherapeutic device assembly and packaging equipment in the $50–$100MM 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 and packaging
- Experience with combination products and associated regulatory expectations
Responsibilities
- Lead development and delivery of device assembly and packaging specifications and drawings (URS, 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 and 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 aseptic device assembly and packaging equipment, collaborating with cross‑functional partners and strategic equipment vendors
- Serve as DAP Subject Matter Expert (SME) for large‑molecule, aseptic drug product projects, interfacing 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 stakeholder and partner management skills
- Maintain current knowledge of industry trends, aseptic processing technologies, 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
Benefits
- Inclusive work environment
- Respect for diversity and dignity
- Recognition of merit
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What This Job Offers
Job Type
Full-time
Career Level
Senior
