Computer System Validation (CSV) Specialist with genAI – GxP
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Job Location:
Houston, MS - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
#ZR
Job Title: Computer System Validation (CSV) Specialist with genAI GxP
Visa: GC H4EAD GCUSC GEAD (Rate is on w2 )
Work Type: 100% Remote
Work Type: 100% Remote
Job Summary
We are looking for a Computer System Validation (CSV) Specialist with expertise in GxP-regulated environments to modernize validation processes using Generative AI (GenAI). This role focuses on ensuring that computerized systems meet regulatory requirements while leveraging AI to improve efficiency traceability and compliance across validation lifecycle activities.
Key Responsibilities
Lead and execute Computer System Validation (CSV) activities in compliance with GxP guidelines (GAMP 5 21 CFR Part 11 Annex 11).
Design and implement GenAI-driven solutions to enhance validation processes including:
Automated generation of validation documents (URS FS DS IQ/OQ/PQ protocols)
Intelligent test case generation and optimization
Automated traceability matrix creation and updates
Use GenAI to review and validate:
Requirements for completeness and compliance
Test scripts for coverage gaps
Deviations and CAPAs for consistency and root cause insights
Ensure systems meet data integrity principles (ALCOA).
Collaborate with QA IT and business stakeholders to define validation strategies.
Maintain validation documentation in alignment with regulatory expectations.
Support audits and inspections by regulatory bodies such as the U.S. Food and Drug Administration and European Medicines Agency.
Evaluate risks associated with AI/ML usage in GxP systems and implement appropriate controls.
Ensure GenAI models and outputs are validated explainable and compliant.
Required Skills & Qualifications
Bachelor s degree in Computer Science Life Sciences Engineering or related field.
4 years of experience in Computer System Validation (CSV) within GxP environments.
Strong knowledge of:
GAMP 5 framework
21 CFR Part 11
EU Annex 11
Data integrity (ALCOA) principles
Experience with validation documentation:
URS FS DS
IQ/OQ/PQ
Traceability matrices
Hands-on experience with GenAI / LLMs (e.g. prompt engineering API usage).
Familiarity with validation of SaaS/cloud systems.
Understanding of risk-based validation approaches.
