CSV Gen AI & SAP Consultant

About the role

We are seeking a seasoned Computer System Validation (CSV) professional with over five years of hands-on experience in GxP-regulated environments. The ideal candidate will have a strong background in validating and deploying enterprise systems such as SAP ERP, WMS, and supply chain applications, along with expertise in CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.

This role also requires demonstrated experience delivering 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.

Responsibilities

• 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.
• Apply QA methodologies to design, review, and approve test plans, system/UAT test scripts, and test procedures.
• Provide validation guidance, timely reviews, and escalations to TQ management.
• Lead or collaborate with teams, including remote teams, to support multiple changes and projects simultaneously.

Requirements

• 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
• Hands-on experience validating and deploying SAP ERP, WMS, and enterprise supply chain applications.
• Strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
• Experience with Generative AI and Agentic AI solutions, including validation and governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, and risk-based compliance approaches.
• 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 manage multiple changes/projects simultaneously.