CSV Consultant(Computer System Validation – GenAI, Agentic , SAP

About the Role

This position requires demonstrated delivery experience with Generative AI and Agentic AI solutions, including validation and governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle controls, and risk-based compliance approaches in regulated environments.

Additionally, the role mandates SAP ERP experience and expertise in Computer System Validation (CSV) within GxP-regulated environments.

Responsibilities

• Validate and deploy SAP ERP, WMS, and enterprise supply chain applications in GxP-regulated environments.
• Develop, write, and execute documentation for all aspects of validation deliverables, including requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reports.
• Review system test scripts, user acceptance test scripts, traceability matrices, and design specifications.
• Design, review, and approve test plans, system/UAT test scripts, and test procedures using QA methodologies.
• Provide validation guidance, timely reviews, and escalations to management.
• Work collaboratively with remote teams and manage multiple changes or projects simultaneously.

Requirements

• 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
• Strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience in FDA and/or globally regulated environments with a solid understanding of GxP standards and risk-based validation.

Skills

• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team, or accomplish tasks independently.
• Ability to work with remote teams and support multiple projects simultaneously.