Sr. Principal Process Engineer –Packaging

Qualifications

• Education:
• A minimum Bachelor's 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.
• For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
• 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.
• Required Skills:
• Preferred Skills: