Senior Manager, Drug Product Optical Inspection System User
Johnson & Johnson
Wilson, North Carolina, United States of America
8 years pharmaceutical industry experience
3+ years optical inspection sme
Cgmp regulatory compliance expertise
This role serves as the recognized Subject Matter Expert for Optical Inspection across the Drug Product facility with full technical ownership of 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 with full technical ownership of manual and automated visual inspection processes.
The position requires leading safety-related reviews including HAZOP, machine safety, and ergonomic assessments while ensuring alignment with cGMP and global regulatory expectations.
Candidates must demonstrate expert-level knowledge of cGMP regulations with a proven record of leading inspections, audits, and resolving complex compliance gaps as the accountable SME.
Matching Summary
This role serves as the recognized Subject Matter Expert for Optical Inspection across the Drug Product facility with full technical ownership of manual and automated visual inspection processes.
Skills & Requirements
Must-have
8 years pharmaceutical industry experience
3+ years optical inspection SME
cGMP regulatory compliance expertise
Parenteral product visual inspection
Validation IQ OQ PQ execution
Defect library and standards definition
Nice-to-have
Lean Six Sigma certifications
Digitalization and robotics evaluation
Entrepreneurial ownership mindset
Cross-functional team leadership
Advanced automation technology knowledge
Key Requirements
Bachelor's degree in Life Sciences, Pharmacy, or Engineering
Minimum 8 years pharmaceutical industry experience