Senior Manager, Drug Product Device Assembly and Packaging

Senior Production Manager, Device Assembly and Packaging At 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. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Manufacturing Manufacturing Pharmaceutical Process Operations 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. 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. A Bachelor's or higher degree in Life Sciences, Pharmacy, or Engineering is 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 35 years of hands-on experience serving as a Subject Matter Expert in Device Assembly and Packaging (DAP) for aseptically filled parenteral products Proven experience applying and maintaining cGMP compliance within aseptic DP operations, including participation in regulatory inspections and audit readiness activities. Proficiency with automated, digit