Senior Manager, Drug Product Optical Inspection System User
J&J FAMILY OF COMPANIES
Wilson, North Carolina, United States of America
8+ years pharmaceutical industry experience
3+ years optical inspection sme role
Cgmp regulatory compliance expertise
This role serves as the recognized Subject Matter Expert for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes
Job Summary
This role serves as the recognized Subject Matter Expert for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes.
The position requires leading safety-related reviews, approving User Requirement Specifications, and acting as the final technical authority for inspection-related decisions in alignment with cGMP regulations.
Candidates must demonstrate expert-level knowledge of digitalization, automation, and robotics technologies while ensuring all inspection activities are delivered within approved budget and project schedules.
Matching Summary
This role serves as the recognized Subject Matter Expert for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes.
Skills & Requirements
Must-have
8+ years pharmaceutical industry experience
3+ years optical inspection SME role
cGMP regulatory compliance expertise
Parenteral product visual inspection knowledge
Validation documentation IQ OQ PQ authoring
Defect library and standard definition
Nice-to-have
Lean Six Sigma certifications
Digitalization and robotics implementation
Entrepreneurial mindset and innovation
Cross-functional team leadership skills
Advanced automation technology evaluation
Key Requirements
Bachelor's degree in Life Sciences, Pharmacy, or Engineering required
Minimum 8 years pharmaceutical industry experience including people leadership
Minimum 3+ years as SME in Optical Inspection for parenteral products
Expert knowledge of cGMP regulations and regulatory inspections
Full-time on-site support required in Wilson, North Carolina