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

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About Innovative Medicine

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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 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.

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

Qualifications

Education:

• Bachelor's degree in Engineering required (Mechanical Engineering preferred) Bachelor's degree in Engineering required (Mechanical Engineering preferred)

• Master's degree or MBA preferred Master's 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 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 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 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 Proven ability to build and maintain strong partnerships with cross-functional stakeholders

• Ability to lead and influence multicultural teams and remote collaborators 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 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 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 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 cGMP requirements for aseptic device assembly and packaging

• Serialization and aggregation processes for finished biotherapeutic drug products Serialization and aggregation processes for finished biotherapeutic drug products

• EHS requirements, with emphasis on EHS-by-design and construction safety EHS requirements, with emphasis on EHS-by-design and construction safety

• Start-up processes and Commissioning & Qualification (C&Q) of aseptic equipment Start-up processes and Commissioning & Qualification (C&Q) of aseptic equipment

• Engineering design principles for biotherapeutic drug product manufacturing Engineering design principles for biotherapeutic drug product manufacturing

• Construction, procurement, project controls, and project scheduling Construction, procurement, project controls, and project scheduling

• Strong technical depth, problem-solving capability, communication skills, and decision-making ability in a fast-paced environment 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 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 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 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 supporting greenfield or brownfield GMP aseptic manufacturing facility start-ups in device assembly and packaging

• Experience with combination products and associated regulatory expectations 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. 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 https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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