Senior Manager, Drug Product Device Assembly And Packaging (dap) System User
Johnson & Johnson
Wilson, North Carolina, United States of America
Device assembly and packaging (dap) sme
Cgmp and aseptic processing
User requirement specifications (urs)
This role offers a unique opportunity to help build a greenfield Drug Product facility from the ground up
Job Summary
This role offers a unique opportunity to help build a greenfield Drug Product facility from the ground up.
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.
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.
Matching Summary
This role offers a unique opportunity to help build a greenfield Drug Product facility from the ground up.
Skills & Requirements
Must-have
Device Assembly and Packaging (DAP) SME
cGMP and aseptic processing
User Requirement Specifications (URS)
engineering deliverables review
aseptic processing design contribution
operator training strategies development
Nice-to-have
Lean/Six Sigma certifications
harmonization and best-practice adoption
proactive risk identification and mitigation
Key Requirements
Bachelor's or higher degree in Life Sciences, Pharmacy, or Engineering
Minimum 8 years of experience in pharmaceutical industry
Minimum 3-5 years hands-on experience in Device Assembly and Packaging (DAP)
Proven experience applying and maintaining cGMP compliance
Proficiency with automated, digital, and robotic DAP systems