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: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 facility
- Provide 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 batches
- Actively support cycle development, cleaning, and hold time studies
- Preparation 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 met
- Lead 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.
QualificationsEducation:- 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 environments
- A 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 products
- Strong working knowledge of aseptic processing principles, contamination control strategies, and sterile manufacturing requirements, including barrier technologies
- Proven 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 organization
- Strong 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.
Required Skills: Preferred Skills:Agile Manufacturing, Business Intelligence (BI), Change Management, Chemistry, Manufacturing, and Control (CMC), Competitive Landscape Analysis, Consulting, Cost-Benefit Analysis (CBA), Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Industry Analysis, Manufacturing Standards, Operational Excellence, Organizational Knowledge, Organizing, Plant Operations, Process Optimization, Program Management, Technical Credibility
