Computer System Validation

Ameri Partners is seeking a CSV Analyst to support validation documentation and test execution for GxP computerized systems in a regulated life sciences environment.

The role will work closely with Validation, Quality Assurance, IT, system owners, and business users to ensure computerized systems are appropriately documented, tested, and maintained in a validated state.

Key Responsibilities

• Prepare and maintain CSV deliverables including URS, Validation Plans, IQ/OQ/PQ protocols, RTMs, and Validation Summary Reports .
• Execute approved test scripts and document results against defined acceptance criteria.
• Perform functional, negative, and regression testing.
• Verify system controls including user access, security roles, audit trails, electronic signatures, and backup/restore functionality.
• Document discrepancies and deviations and support investigation and approved retesting activities.
• Maintain traceability between requirements, test cases, results, and deviations.
• Review validation packages for completeness, accuracy, and Good Documentation Practices (GDP) .
• Support change controls, periodic reviews, document routing, and audit readiness.
• Coordinate with QA, IT, system owners, and technical teams to resolve validation and testing issues.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field, or equivalent relevant experience.
• 2+ years of CSV experience in pharmaceutical, biotechnology, or another regulated environment.
• Hands-on experience preparing validation documentation and executing test protocols.
• Working knowledge of GxP, 21 CFR Part 11, GAMP 5, and ALCOA+ principles .
• Strong technical writing, documentation, communication, and attention to detail.

Preferred Qualifications

• Experience with validation or document management platforms such as Kneat Gx or Veeva Vault .
• Exposure to laboratory, manufacturing, or enterprise computerized systems.