Computer System Validation (CSV) Lead – SAP & GenAI Validation

Raas Infotek; Raritan (NJ); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Raas Infotek is seeking a Computer System Validation (CSV) Lead for SAP & GenAI validation in Raritan, NJ. The role demands 5+ years of CSV experience in GxP environments, with hands-on validation of SAP ERP, WMS, and enterprise supply chain applications.

You will drive validation deliverables, governance of AI-enabled systems, and risk-based compliance in regulated settings, collaborating with QA, cross‑functional teams, and remote partners.

Qualifications

• 5+ years of CSV experience in GxP environments with hands-on validation of SAP ERP and WMS.
• Experience with Generative AI and AI agents governance in regulated settings.
• Experience in Pharmaceuticals/biotech/medical devices; FDA/global regulation exposure.
• Ability to write and review validation deliverables and documents.

Responsibilities

• Lead CSV validation deliverables and test protocols.
• Govern AI-enabled systems validation and governance.
• Collaborate with QA, cross-functional teams, and remote partners.
• Ensure traceability, risk assessment, and inspection readiness.

Skills

CSV validation

GxP compliance

Leadership

Communication

Remote collaboration

Tools

SAP ERP

WMS

AI governance tools

Job description

We have an urgent position listed below. Please send your most recent resume along with the expected rate if you are interested.

Job Role: Computer System Validation (CSV) Lead – SAP & GenAI Validation

Location: Raritan, NJ(Hybrid)

Job Description:

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.

• 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

Thanks & Regards

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