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

Job Title

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

Wilson, North Carolina, United States of America

Posted on Apr 19 2026; anticipated close May 01 2026

Supply Chain Manufacturing

Manufacturing Pharmaceutical Process Operations

Senior Manager, Manufacturing Pharmaceutical Process Operations (P8)

As part of a newly established team, this role offers an opportunity to help build a greenfield Drug Product facility from the ground up. The position begins as a single contributor and transitions to a Senior Production Manager overseeing the Device Assembly and Packaging operations team.

• Serve as the Device Assembly and Packaging (DAP) subject matter expert for 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 align them 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.
• Contribute 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 with global parenteral DP sites, engineering partners, quality, automation, MSAT, and supply chain teams to harmonize best practices and ensure successful project delivery.
• Develop and implement operator training strategies, including qualification plans, technical training, aseptic behavior training, and knowledge transfer for DAP operations.
• Review deliverables from concept refresh, basis‑and detailed engineering (PFDs, P&IDs, process descriptions, functional design specifications, equipment specifications).
• Write and/or review Process Support Operational documentation (Master Batch Records, SOPs, WIs).
• Support commissioning and qualification batches, cycle development, cleaning, and hold time studies.
• Prepare and review, then approve validation related qualification documents and manage execution of associated tasks (water batch, engineering batch, aseptic process simulation, validation batches).
• Identify required spare parts per the approved spare part list for support systems and coordinate procurement.
• Monitor and ensure all user requirements are met.
• Lead the development, review, and approval of process support operational documentation, including MBRs, SOPs, 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.
• Respond timely and accurately 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.

Education

• 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

• Minimum eight years of experience in the pharmaceutical industry with technical leadership in sterile Drug Product manufacturing environments.
• Minimum 3–5 years of hands‑on experience as a DAP subject matter expert for aseptically filled parenteral products.
• Strong knowledge of aseptic processing principles, contamination control strategies, and sterile manufacturing requirements, including barrier technologies.
• Experience applying and maintaining cGMP compliance within…