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# CSV Validation Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Minneapolis, MN, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Software Documentation, Data Integrity, System Testing, Test Scripts, Computerised Systems, Information Technology, GXP
- **Published:** October 31, 2026
- **Apply:** https://www.juju.com/job/15_3e3575c4

## About the Role

* Bachelor's degree in computer science, Information Technology, Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field.
 * A master's degree or relevant professional certification in validation, quality, compliance, or a related discipline is a plus.
 * 3 years of experience in Computer System Validation (CSV), IT validation, or a closely related validation/compliance role within a regulated environment.
 * Experience working in pharmaceutical, biotechnology, medical device, healthcare, or other GxP-regulated industries.
 * Hands-on experience developing and executing validation documentation, protocols, and test scripts.

## Description

We are seeking an experienced CSV (Computer System Validation) Engineer to support the validation and compliance of GxP-regulated computerized systems in a regulated pharmaceutical, biotech, medical device, or similar environment. The CSV Engineer will be responsible for developing and executing risk-based validation strategies, preparing validation documentation, performing testing, managing deviations and CAPAs, and ensuring computerized systems meet intended-use, regulatory, quality, and data integrity requirements.

Roles and Responsibilities

 * Develop and execute Computer System Validation (CSV) strategies, plans, protocols, test scripts, and validation reports.
 * Perform and document risk assessments, system impact assessments, traceability assessments, and change control activities.
 * Support validation of GxP-regulated computerized systems in accordance with applicable regulatory requirements, industry standards, and company procedures.
 * Execute and document validation test scripts, including identification and resolution of discrepancies and deviations.
 * Support deviation investigations, root-cause analysis, CAPA, and corrective actions related to computerized systems.
 * Ensure computerized systems comply with applicable FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
 * Apply risk-based validation methodologies throughout the system lifecycle.
 * Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
 * Collaborate closely with Quality Assurance, IT, Engineering, Manufacturing, Validation, and business stakeholders to ensure systems meet intended-use and compliance requirements.
 * Review system documentation, test evidence, configuration records, and other validation deliverables for completeness and compliance.
 * Support audit and inspection readiness by providing validation documentation, test evidence, and compliance records.
 * Identify validation gaps and support remediation activities to maintain the validated state of computerized systems.