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

Location: Wilson, North Carolina, United States; full-time on-site support required. Facility design will take place at an engineering firm with more than 75% travel required until the project transitions to the Wilson plant site.

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative medicines with a focus on improving patient outcomes.

What you will do

• Serve as the Device Assembly and Packaging 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 for DAP processes, equipment, systems, cGMP compliance, aseptic processing, and regulatory readiness.
• Author, review, and approve user requirements, process flow diagrams, P&IDs, functional design specifications, equipment specifications, automation strategies, and process descriptions.
• Support aseptic processing design, including material and personnel flows, environmental controls, line segregation, barrier or isolator strategies, RABS, and contamination prevention.
• Lead development and approval of Master Batch Records, SOPs, work instructions, packaging instructions, training plans, and knowledge-transfer materials.
• Support commissioning and qualification batches, cycle development, cleaning and hold-time studies, validation activities, spare-parts planning, and risk mitigation through facility start-up and commercialization.

Requirements

• Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering; a Master’s degree or higher is preferred.
• At least 8 years of pharmaceutical industry experience with technical leadership in sterile drug product manufacturing.
• 3–5 years of hands-on subject matter expertise in device assembly and packaging for aseptically filled parenteral products.
• Strong knowledge of aseptic processing, contamination control strategies, sterile manufacturing requirements, barrier technologies, and cGMP compliance.
• Experience with automated, digital, and robotic DAP systems, regulatory inspections, audit readiness, validation, and qualification activities.
• Ability to lead cross-functional teams and influence engineering, quality, automation, MSAT, and supply chain stakeholders.

Nice to have

• Master’s degree or higher.
• Lean/Six Sigma certification.

Culture & Benefits

• Work within a newly established team building a greenfield drug product facility from the ground up.
• Collaborate with parenteral drug product sites across the global Johnson & Johnson network.
• Help shape the organization, culture, capabilities, and recruitment ramp-up for the new facility.
• Operate within an inclusive work environment focused on healthcare innovation and patient impact.