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ClinDCast LLC

CSV Consultant

Posted 2 months ago
United States
$45 - $50 per hour
5-10 years experience
sap erp medical compliance
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AI Summary

The CSV Consultant will perform validation activities for SAP ERP and AI-enabled systems while ensuring compliance with global regulatory standards. They will develop validation documentation, review test protocols, and support audit readiness across cross-functional teams.

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.

Key Responsibilities:

  • 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.
Required Skills:

  • 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.

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