CSV Consultant

ClinDCast LLC; Raritan (NJ); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Flexible work from home

Job summary

ClinDCast LLC is seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI in a GxP-regulated environment. The ideal candidate will validate enterprise applications while ensuring FDA and global regulatory standards compliance.

The role involves developing validation documentation, validating AI-enabled systems, and ensuring readiness for audits. Flexible work-from-home options are available, with collaboration across remote teams.

Qualifications

• 5+ years of CSV validation experience in GxP-regulated environments.
• Strong SAP ERP validation experience.
• Experience validating Generative AI and AI governance.
• Knowledge of FDA regulations, 21 CFR Part 11, Annex 11, and risk-based validation.
• Experience in pharmaceutical, biotechnology, or medical device industries.
• Excellent documentation, analytical, communication, and problem-solving skills.

Responsibilities

• 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, FDA regulations, 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.

Skills

CSV Validation

SAP ERP

Generative AI/AI governance

GxP-regulated environments

FDA regulations

Documentation & communication

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.

Key Responsibilities

• 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.

Required Skills

• 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.