Senior Manager, Drug Product Device Assembly and Packaging (DAP) System User

Biopharma Careers; Wilson (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson is hiring for a Senior Production Manager to lead Device Assembly and Packaging (DAP) within a new greenfield drug product facility in Wilson, NC. You will drive aseptic manufacturing readiness, partner across engineering, quality, automation, MSAT, and supply chain, and ensure regulatory compliance and on-time delivery.

The role requires 8+ years in pharmaceutical sterile manufacturing, SME in DAP, and strong problem-solving abilities.

Qualifications

• Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering required.
• Experience in sterile Drug Product manufacturing environments preferred.
• Strong knowledge of aseptic processing principles and contamination control.

Responsibilities

• Serve as the DAP SME for design, start-up, commissioning, qualification, and routine operation of an aseptic Drug Product facility.
• Provide leadership to ensure DAP processes, equipment, and systems meet cGMP and regulatory expectations.
• Author/review URS and ensure alignment with aseptic strategy and packaging needs.
• Review/approve PFDs, P&IDs, FDS, equipment specs, automation strategies, and process descriptions.
• Develop operator training strategies and qualification plans for DAP operations.
• Prepare/approve MBRs, SOPs, WI and packaging/assembly instructions.

Skills

Aseptic processing

cGMP compliance

DAP leadership

Cross-functional collaboration

Lean/Six Sigma

Robotics automation

Education

Bachelor’s or higher in Life Sciences/Pharmacy/Engineering

Master’s preferred

Tools

Automated/robotic DAP systems

Process automation software

Job description

## About this opportunityAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.**Job Function:**Supply Chain Manufacturing**Job Sub Function:**Manufacturing Pharmaceutical Process Operations**Job Category:**Professional**All Job Posting Locations:**Wilson, North Carolina, United States of America**Job Description:****About Innovative Medicine**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.**Learn more at** **https://www.jnj.com/innovative-medicine**Learn more and apply to this exciting new role!As part of a newly established team, this role offers a unique opportunity to help build a greenfield Drug Product facility from the ground up. You will work in close partnership with parenteral DP sites across the J&J network, providing leadership in shaping the organization, culture, and capabilities while driving the recruitment ramp‐up to support project milestones, timelines, and budget. This role will transition from a single contributor role into a Senior Production Manager role with responsibility for the Device Assembly and Packaging operations team.**Key Responsibilities:**Serve as the Device Assembly and Packaging (DAP) Subject Matter Expert for the design, start‐up, commissioning, qualification, and routine operation of an aseptic Drug Product manufacturing facilityProvide technical and operational leadership to ensure DAP processes, equipment, and systems comply with cGMP, aseptic processing requirements, and global regulatory expectations.Author, review, and approve User Requirement Specifications (URS) and ensure alignment with aseptic processing strategy, device assembly needs, packaging requirements, and product quality attributes.Review and approve engineering deliverables across project phases, including Process Flow Diagrams (PFDs), P&IDs, functional design specifications, equipment specifications, automation strategies, and process descriptions specific to DAP and aseptic operations.Act as a key contributor to aseptic processing design, including material and personnel flows, environmental controls, line segregation, barrier/isolator or RABS strategies, and contamination prevention measures related to DAP.Collaborate closely with global parenteral DP sites, engineering partners, quality, automation, MSAT, and supply chain teams to ensure harmonization, best‐practice adoption, and successful project delivery.Develop and implement operator training strategies, including qualification plans, technical training, aseptic behavior training, and knowledge transfer for DAP operations.Review the deliverables from concept refresh, basis-and detailed engineering (e.g.: PFD’s , P&ID’s, process descriptions, functional design specifications, equipment specifications)Writing and/or review of Process Support Operational documentation (Master Batch Records, SOP’s, WI’s)Actively support all commissioning and qualification batchesActively support cycle development, cleaning, and hold time studiesPreparation and execution review & approval of validation related qualification documents and the resourcing of execution of associated tasks (water batch, engineering batch, aseptic process simulation, validation batches)The identification of required spare parts in accordance with the approved spare part list for the support systems and liaise with relevant parties for their procurement.Monitoring and ensuring all user requirements are metLead the development, review, and approval of process support operational documentation, including Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Work Instructions (WIs), and packaging/device assembly instructions.Define spare parts strategies for DAP and associated support systems, ensuring availability, lifecycle management, and alignment with maintenance and reliability plans.Ensure timely and accurate responses to information requests, regulatory questions, and audit inquiries related to DAP and aseptic manufacturing readiness.Execute all responsibilities within approved project timelines and budgets, proactively identifying risks and mitigation strategies to support on‐time facility start‐up and commercialization readiness.**Qualifications****Education:**A Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering is required; a Master's or higher degree is preferred.**Experience and Skills:****Required:**A minimum of 8 years of experience in the pharmaceutical industry, with demonstrated technical leadership in sterile Drug Product manufacturing environmentsA minimum of 3–5 years of hands-on experience serving as a Subject Matter Expert in Device Assembly and Packaging (DAP) for aseptically filled parenteral productsStrong working knowledge of aseptic processing principles, contamination control strategies, and sterile manufacturing requirements, including barrier technologiesProven experience applying and maintaining cGMP compliance within aseptic DP operations, including participation in regulatory inspections and audit readiness activities.Proficiency with automated, digital, and robotic DAP systems used in sterile Drug Product manufacturing, with the ability to translate technology into compliant and efficient operations.Strong analytical and problem-solving skills, with a track record of identifying and implementing practical solutions in complex aseptic manufacturing environments.Demonstrated ability to lead cross-functional teams and influence stakeholders across engineering, quality, automation, MSAT, and supply chain organizationStrong analytical and problem-solving skills, with a track record of identifying and implementing practical solutions in complex aseptic manufacturing environments.**Preferred:**Lean/Six Sigma certifications**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.