CSV Specialist - Regulated Systems Validation Expert

Veg Group; Wilson (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. in Wilson, NC seeks a Computer System Validation (CSV) Specialist to support validation activities for computerized systems in a regulated environment.

You will contribute to system lifecycle documentation and data integrity with 3–4 years of hands-on CSV experience. Responsibilities include developing validation documentation, executing tests, and ensuring compliance with 21 CFR Part 11, GxP, and data integrity.

Qualifications

• Bachelor’s degree required in a technical discipline.
• 3–4 years CSV in a regulated environment (pharma/biotech/medical devices).
• Knowledge of GAMP 5, 21 CFR Part 11, GxP and data integrity.
• Experience developing and executing validation documentation and testing.
• Strong documentation, analytical and problem-solving skills.
• Ability to work cross-functionally with technical and quality teams.
• Strong written and verbal communication.

Responsibilities

• Support validation and lifecycle management of GxP computerized systems.
• Develop, review, and execute validation docs: URS, FDS, Risk Assessments, Validation Plans, IQ/OQ/PQ, Test Scripts, Traceability Matrices, Validation Summary Reports.
• Execute and document system testing; resolve discrepancies and deviations.
• Support system implementation, upgrades, enhancements and periodic reviews.
• Perform risk assessments per regulatory requirements and company procedures.
• Ensure compliance with 21 CFR Part 11, GxP, data integrity and eRecords/eSign.
• Collaborate with IT, Engineering, Quality, Manufacturing, Automation and system owners.
• Support change controls, deviations, CAPAs and retirement activities.
• Assist with audit and inspection readiness; maintain validation documentation.

Skills

GxP compliance

GAMP 5

21 CFR Part 11

Data integrity

Validation testing

IQ/OQ/PQ

Risk assessments

Traceability matrices

Documentation

Cross-functional work

Education

Bachelor’s degree in Engineering, Computer Science, IT, Life Sciences

Tools

Power BI

Job description

Validation & Engineering Group, Inc. in Wilson, NC seeks a Computer System Validation (CSV) Specialist to support validation activities for computerized systems in a regulated environment.

You will contribute to system lifecycle documentation and data integrity with 3–4 years of hands-on CSV experience. Responsibilities include developing validation documentation, executing tests, and ensuring compliance with 21 CFR Part 11, GxP, and data integrity.