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# CSV Validation Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Plymouth, MN, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Data Integrity, System Testing, Electronic Filing System, Test Scripts, Information Technology, GXP
- **Published:** November 12, 2026
- **Apply:** https://www.careerbuilder.com/job-details/csv-validation-engineer-plymouth-mn--4416ce2f-242d-4449-9ec1-ad5911413488

## About the Role

System Validation, Computer Systems, Strategic Planning, Validation Documentation, Process Validation, Risk Analysis, Traceability, Change Control, Regulations, GxP, * 8 years Experience in Computer System Validation / CSV within pharmaceutical, biotech, medical device, or other regulated environments.

 * Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11, and data integrity.
 * Experience with validation methodologies, risk-based validation, and electronic documentation.
 * Excellent documentation, communication, and stakeholder-management skills.

## Description

We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN.

Roles & Responsibilities:

 * Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports.
 * Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports.
 * Perform risk assessments, impact assessments, traceability, and change control activities.
 * Support validation of GxP-regulated computerized systems in accordance with applicable regulations and company procedures.
 * Collaborate with QA, IT, Engineering, Manufacturing, and business stakeholders to ensure systems meet intended use and compliance requirements.
 * Execute and document test scripts, deviations, investigations, and CAPA activities.
 * Ensure compliance with FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
 * Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
 * Participate in audits and provide validation documentation and evidence as required.