Computer System Validation (CSV)

Csv ConsultantLocation: Raritan, NJ (Hybrid) The ideal candidate will have 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 a good understanding of GxP standards and risk-based validation. Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., 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.