Computer System Validation (CSV) Specialist

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

Current job opportunities are posted here as they become available.

Computer System Validation (CSV) Specialist

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Computer System Validation Specialist

Position Summary

We are seeking a Computer System Validation (CSV) Specialist/Engineer to support validation activities for computerized systems in a regulated manufacturing environment. The ideal candidate will have 3–4 years of hands‑on CSV experience and a solid understanding of GxP requirements, system lifecycle documentation, and data integrity principles.

Key Responsibilities

• Support the validation and lifecycle management of GxP computerized systems.
• Develop, review, and execute validation documentation, including:
  • User Requirements Specifications (URS)
  • Functional/Design Specifications
  • Risk Assessments
  • Validation Plans
  • IQ/OQ/PQ protocols
  • Test Scripts
  • Traceability Matrices
  • Validation Summary Reports
• Execute and document system testing and ensure appropriate resolution of discrepancies and deviations.
• Support system implementation, upgrades, enhancements, and periodic reviews.
• Perform computerized system risk assessments in accordance with applicable regulatory requirements and company procedures.
• Ensure compliance with 21 CFR Part 11, GxP, data integrity, and electronic records/electronic signature requirements.
• Collaborate with IT, Engineering, Quality, Manufacturing, Automation, and system owners throughout the system lifecycle.
• Support change controls, deviations, CAPAs, and system retirement activities as applicable.
• Assist with audit and inspection readiness activities related to computerized systems.
• Maintain accurate and complete validation documentation in accordance with approved procedures.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related technical discipline.
• 3–4 years of experience in Computer System Validation (CSV) within a regulated environment, preferably pharmaceutical, biotechnology, medical device, or life sciences manufacturing.
• Working knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles.
• Experience developing and executing computerized system 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 skills.

Preferred Qualifications

• Experience with Power BI for dashboards, reporting, data visualization, or analytics.
• Experience validating manufacturing, laboratory, quality, or enterprise systems.
• Experience supporting system upgrades, implementation projects, or digital transformation initiatives.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.