CSV Consultant

ClinDCast LLC

Raritan, NJ, United States

about 1 month ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

5 years minimum

Compensation

$93,600.0 - $104,000.0

Working hours

Regular working hours

Job source

www.indeed.com

Tech stack

Artificial Intelligence SAP ERP System Testing Enterprise Software Applications Warehouse Management Systems Large Language Models Generative AI Kubernetes Virtual Agents GXP

Job description

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards., * Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.

Develop and execute validation documentation, including Validation Plans, Requirements, Test Protocols, Traceability Matrix, and Validation Summary Reports.
Validate AI-enabled systems, including Generative AI, Agentic AI, LLM-based applications, AI agents, and orchestration frameworks.
Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations.
Review and approve system testing, UAT scripts, design specifications, and validation deliverables.
Support audit and inspection readiness activities.
Collaborate with cross-functional and remote teams to deliver validation projects.
Provide validation guidance and support multiple projects simultaneously.

Requirements

5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
Strong experience with SAP ERP (mandatory).
Experience validating Generative AI, Agentic AI, LLM-based applications, and AI governance.
Knowledge of GAMP 5, CSA, FDA regulations, 21 CFR Part 11, Annex 11, and risk-based validation.
Experience in the pharmaceutical, biotechnology, or medical device industry.
Excellent documentation, analytical, communication, and problem-solving skills.

Flexible work from home options available.