Computer System Validation

Ameri-partners; Indiana; Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

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.

Qualifications

• Bachelor’s degree in Engineering, CS, Life Sciences or related field.
• 2+ years of CSV experience in regulated environments.
• Hands-on experience preparing validation documentation and executing test protocols.
• Working knowledge of GxP, 21 CFR Part 11, GAMP 5, and ALCOA+ principles.

Responsabilités

• 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 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.

Connaissances

CSV validation experience

GxP compliance

Technical writing

Attention to detail

Communication

Formation

Bachelor’s degree in Engineering, Computer Science, Life Sciences

Outils

Kneat Gx

Veeva Vault

Description du poste

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.