Senior QA Specialist – CSV & Validation Lead

Johnson & Johnson Co.; Wilson (NC); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

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Job summary

Johnson & Johnson is seeking a Senior QA Specialist - CSV for its Biotherapeutics Manufacturing facility in Wilson, North Carolina. The role focuses on quality assurance for computerized system validation across GMP manufacturing, with emphasis on data integrity and regulatory compliance.

Responsibilities include overseeing CSV activities, risk-based validation planning, and qualification documentation, while ensuring system releases and traceability align with FDA/EMA expectations.

Qualifications

• Bachelor's degree in a scientific, engineering, or computer science discipline.
• Minimum 6 years’ experience in biopharma or pharmaceutical industries with hands-on CSV/QA expertise.
• Hands-on CSV QA oversight for automated manufacturing equipment and GMP lab systems (LIMS/CDS).
• Strong knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and data integrity expectations.
• Experience with risk-based validation, supplier documentation, and V&V activities.

Responsibilities

• Author, implement, and maintain CSV and data integrity procedures; contribute to validation plans.
• Provide QA oversight across qualification activities and ensure quality requirements are met.
• Apply GAMP 5, ICH Q9, and ASTM standards to integrate commissioning and qualification activities.
• Review and approve URS/FRS/HDS/SDS, IQ/OQ/PQ, FAT/SAT, and risk assessments as needed.
• Ensure traceability, release readiness of systems, and data lifecycle controls.
• Lead investigations and CAPAs for deviations and test exceptions.
• Oversee cybersecurity, audit trails, and access controls per regulatory guidance.
• Provide QA support for AI-enabled inspection systems and digital validation tools.

Skills

CSV QA oversight

GAMP 5

ICH Q9(R1)

Data integrity

Risk-based validation

SDLC

CAPA investigations

Education

Bachelor's degree in scientific, engineering, or computer science

Tools

Kneat

ValGenesis

DeltaV

Rockwell

Siemens

PAS-X

LabWare

SAP

OSiSoft PI

Empower

Job description

Johnson & Johnson is seeking a Senior QA Specialist - CSV for its Biotherapeutics Manufacturing facility in Wilson, North Carolina. The role focuses on quality assurance for computerized system validation across GMP manufacturing, with emphasis on data integrity and regulatory compliance.

Responsibilities include overseeing CSV activities, risk-based validation planning, and qualification documentation, while ensuring system releases and traceability align with FDA/EMA expectations.