Senior DAP Operations Leader Aseptic Drug Packaging

Johnson & Johnson Innovation; Wilson (NC); On-site; Confidential; Full time

Job summary

Johnson & Johnson Innovation in Wilson, North Carolina, is seeking a senior Production Manager focusing on Device Assembly and Packaging (DAP) for aseptically filled parenteral products. The role drives design, commissioning, qualification, and ongoing operations across global sites while coordinating with engineering, quality, automation, MSAT, and supply chain teams.

Lead training, documentation, and compliance efforts, oversee process flows, and ensure readiness for regulatory inspections.

Qualifications

• 8+ years of experience in the pharmaceutical industry with leadership in sterile Drug Product manufacturing
• 3–5 years hands-on experience as SME in Device Assembly and Packaging for aseptically filled parenteral products
• Strong knowledge of aseptic processing, contamination control, and GMP compliance
• Proven ability to lead cross-functional teams across engineering, quality, automation, MSAT, and supply chain

Responsibilities

• Serve as DAP SME for design, start-up, commissioning, qualification, and routine operation of an aseptic DP facility
• Provide leadership to ensure DAP processes meet cGMP and regulatory expectations
• Author and review URS, ensure alignment with aseptic strategy and packaging needs
• Review engineering deliverables such as PFDs, P&IDs, and equipment specs
• Lead training strategies and qualification plans for DAP operations
• Support commissioning, qualification batches, and validation activities
• Define spare parts strategies and liaise for procurement
• Ensure timely responses to regulatory questions and audits
• Manage on-site start-up and ramp-up to commercialization readiness
• Travel >75% during project phases before plant site shift

Skills

8+ years pharma

DAP SME

Aseptic processing

cGMP compliance

Automation & robotics

Cross-functional leadership

Analytical problem-solving

Education

Bachelor's degree in Life Sciences/Engineering

Master's degree preferred

Tools

PFDs

P&IDs

URS

MBR/SOPs/WIs

Job description

Johnson & Johnson Innovation in Wilson, North Carolina, is seeking a senior Production Manager focusing on Device Assembly and Packaging (DAP) for aseptically filled parenteral products. The role drives design, commissioning, qualification, and ongoing operations across global sites while coordinating with engineering, quality, automation, MSAT, and supply chain teams.

Lead training, documentation, and compliance efforts, oversee process flows, and ensure readiness for regulatory inspections.