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

< style="line-height: 1.3em; font-size: 1.2em; margin-bottom: 8px; color: rgb(32, 32, 32); font-family: "Segoe UI", "Lucida Sans Unicode", "Lucida Grande", sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; margin-top: 5px;">Must:</>

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

• SAP ERP Experience mandatory

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

5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
Demonstrated delivery experience with Generative AI and Agentic AI solutions, including validation/governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle controls, and risk-based compliance approaches in regulated environments.
Experience in the Pharmaceutical, biotechnology, or medical device industry
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
Strong verbal and written communication skills.
Ability to work as a team player, lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management.