CSV Consultant

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.