Sr. Princ. Process Engineer – DP Aseptic Biotherapeutic Device Assembly and Packaging Equipment

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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 endtoend (E2E) process engineering ownership of device assembly and packaging equipment from conceptual design commissioning and qualification and initial equipment start-up for commercial manufacturing.

Key Responsibilities:

• Lead development and delivery of device assembly and packaging specifications and drawings (URS data sheets technical specifications P&IDs PFDs) supporting largemolecule 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 crossfunctional partners and strategic equipment vendors

• Serve as DAP Subject Matter Expert (SME) for largemolecule 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 startup 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 datadriven insights and market intelligence to guide technical and strategic decisions

• Ensure full compliance with company policies cGMPs regulatory requirements and customer specifications

Qualifications

Education:

• Bachelors degree in Engineering required (Mechanical Engineering preferred)

• Masters degree or MBA preferred

Experience and Skills:

Required:

• 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 crossfunctional 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

• Serialization and aggregation processes for finished biotherapeutic drug products

• EHS requirements with emphasis on EHSbydesign and construction safety

• Startup 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 problemsolving capability communication skills and decisionmaking ability in a fastpaced environment

• Passion for driving innovation in aseptic equipment and facility design

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 largemolecule biotherapeutic drug product environments

• Experience supporting greenfield or brownfield GMP aseptic manufacturing facility startups in device assembly and packaging

• Experience with combination products and associated regulatory expectations

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 of Wilson NC.

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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 by 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 internal employees contact AskGS to be directed to your accommodation resource.

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