Senior QA Specialist, CSV – Validation Lead for Biopharma

Biopharma Asia; Wilson (NC); On-site; USD 140,000 - 170,000; Full time

Job summary

Johnson & Johnson in Wilson, North Carolina seeks a Senior QA Specialist - CSV for our BioNC biotherapeutics manufacturing facility. You will lead CSV validation, data integrity, and regulatory alignment across projects.

Responsibilities include overseeing URS/FS validation, audit trails, 21 CFR Part 11 compliance, and AI-enabled inspection systems within a GMP environment at the new site.

Qualifications

• Bachelor's degree in a scientific, engineering, or computer science discipline and 6+ years in pharma/biotech quality or CSV.

Responsibilities

• Author, implement, and maintain CSV data integrity procedures and documentation for a new Wilson, NC manufacturing site.

Skills

Quality Assurance

CSV Validation

Data Integrity

Cybersecurity

Education

Bachelor's degree in life sciences or engineering

Tools

LIMS

GxP systems

ISA/IEC 62443

21 CFR Part 11

Job description

Johnson & Johnson in Wilson, North Carolina seeks a Senior QA Specialist - CSV for our BioNC biotherapeutics manufacturing facility. You will lead CSV validation, data integrity, and regulatory alignment across projects.

Responsibilities include overseeing URS/FS validation, audit trails, 21 CFR Part 11 compliance, and AI-enabled inspection systems within a GMP environment at the new site.