CSV Consultant
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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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