Sr. Principal Process Engineer –Packaging

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As part of the Global Process Engineering team the Sr. Principal Process Engineer Packaging serves as the recognized technical authority and domain expert for packaging equipment. This role is accountable for end-to-end (E2E) process engineering ownership of packaging equipment from conceptual design commissioning and qualification through initial equipment start-up for commercial manufacturing.

Key Responsibilities:

• Leads development and delivery of packaging 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 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 packaging equipment for biotherapeutic drug products collaborating with multi-functional partners and strategic equipment vendors

• Serve as the Packaging 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 alignment across evolving business needs applying strong collaborator and partner leadership skills

• Maintain current knowledge of industry trends aseptic processing techniques 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

Qualifications

Education:

• A minimum Bachelors Degree in engineering required (Mechanical Engineering preferred)

• MS or MBA preferred

Experience and Skills:

Required:

• A minimum of 10 years packaging equipment process engineering and/or capital project execution experience within a large-molecule biotherapeutic and synthetics environment

• Strong background in large-molecule biotherapeutic drug product device packaging equipment principles

• Experience leading packaging equipment process engineering activities across the full product lifecycle preferably within capital project execution

• Shown ability to build and maintain strong partnerships with multi-functional customers

• Ability to lead and influence multicultural teams and remote collaborators

• Extensive interaction with external partners (A&E firms construction teams and equipment vendors) as Packaging Equipment SME

• Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design of 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 the following:

• cGMP requirements for biotherapeutic large-molecule packaging equipment

• Serialization and aggregation processes for finished biotherapeutic drug products

• 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

Preferred:

• Demonstrated leadership of capital projects for aseptic large-molecule biotherapeutic packaging 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 for packaging equipment

• Experience with combination products and associated regulatory expectations

• Experience with automated case packers and automated palletizers

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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