Role - CSV Consultant
Location -Raritan, NJ(Hybrid)
Job Details:
" 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, ,S, 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