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.
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