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# CSV Consultant

- **Company:** ClinDCast LLC
- **Location:** Raritan, NJ, United States (Remote available)
- **Experience:** Expert
- **Salary:** $93,600.0 - $104,000.0
- **Contract:** Permanent contract
- **Skills:** Artificial Intelligence, SAP ERP, System Testing, Enterprise Software Applications, Warehouse Management Systems, Large Language Models, Generative AI, Kubernetes, Virtual Agents, GXP
- **Published:** August 3, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=7115c80fd95d03f9

## About the Role

* 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
 * Strong experience with SAP ERP (mandatory).
 * Experience validating Generative AI, Agentic AI, LLM-based applications, and AI governance.
 * Knowledge of GAMP 5, CSA, FDA regulations, 21 CFR Part 11, Annex 11, and risk-based validation.
 * Experience in the pharmaceutical, biotechnology, or medical device industry.
 * Excellent documentation, analytical, communication, and problem-solving skills.

Flexible work from home options available.

## Description

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards., * Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.

 * Develop and execute validation documentation, including Validation Plans, Requirements, Test Protocols, Traceability Matrix, and Validation Summary Reports.
 * Validate AI-enabled systems, including Generative AI, Agentic AI, LLM-based applications, AI agents, and orchestration frameworks.
 * Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations.
 * Review and approve system testing, UAT scripts, design specifications, and validation deliverables.
 * Support audit and inspection readiness activities.
 * Collaborate with cross-functional and remote teams to deliver validation projects.
 * Provide validation guidance and support multiple projects simultaneously.


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