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

Johnson & Johnson Innovative Medicine•Wilson, NC

3d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Lean/Six Sigma certifications

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.