Senior Manager, Drug Product Optical Inspection System User

Johnson & Johnson

Wilson, North Carolina, United States of America
Optical inspection subject matter expert
Parenteral drug product inspection
Cgmp regulations
Serve as the recognized Subject Matter Expert (SME) for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes for parenteral products

Job Summary

  • Serve as the recognized Subject Matter Expert (SME) for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes for parenteral products.
  • Lead the preparation, execution, review, and approval of validation documentation related to optical inspection systems, including IQ/OQ/PQ, inspector qualification, and ongoing performance monitoring.
  • Ensure delivery of all inspection-related activities within approved budget and project schedules, proactively identifying and mitigating technical, regulatory, and operational risks.

Matching Summary

Serve as the recognized Subject Matter Expert (SME) for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes for parenteral products.

Skills & Requirements

Must-have

  • Optical Inspection Subject Matter Expert
  • parenteral drug product inspection
  • cGMP regulations
  • digitalization, automation, and robotics

Nice-to-have

  • thought leadership and innovation
  • entrepreneurial and ownership mindset
  • adaptability and resilience

Key Requirements

  • Bachelor's or higher degree in Life Sciences, Pharmacy, or Engineering
  • Minimum of 8 years of experience in the pharmaceutical industry
  • Minimum of 3+ years as Optical Inspection SME
  • Expert-level knowledge of cGMP regulations

Work Rights

Not specified

Tailored Resume

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