CSV Consultant

ClinDCast

CSV Consultant validating SAP ERP, WMS, and AI-enabled systems in GxP-regulated healthcare environments. Supporting compliant documentation, testing, audits, and validation projects for ClinDCast’s healthcare IT clients.

Posted 8/5/2026full-time🇺🇸 United StatesMid-LevelSenior💰 $45 - $50 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Computer System Validation (CSV) within GxP-regulated environments, focusing on SAP ERP and AI-enabled systems. Proficient in developing validation documentation and ensuring compliance with industry regulations.

Highest-signal resume keywords

Computer System Validation (CSV)SAP ERPGenerative AI ValidationGAMP 5 Compliance21 CFR Part 11 Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Documentation DevelopmentTest Protocols ExecutionTraceability Matrix CreationValidation Summary ReportsUAT Script ReviewRisk-Based Validation

Soft Skills

Analytical SkillsCommunication SkillsProblem-Solving Skills

Tools & Technologies

WMSAI Governance FrameworksOrchestration Frameworks

Industry Keywords

GxP RegulationsPharmaceutical IndustryBiotechnology IndustryMedical Device IndustryCSA Compliance

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

Flexible work from home options available