Computer Systems Validation Engineer

Overview

The Computer Systems Validation Engineer (CSVE) works closely with the Sr. CSVE and with Validation Specialists to ensure all validation activities and deliverables for core products, tools, and study-related projects are properly planned, executed, and documented.

Key Accountabilities of the Computer Systems Validation Engineer include the following:

• Work closely with the Sr. CSVE and Validation Specialists to ensure that all computerized systems, tools, and client projects are appropriately validated.
• Assist in identifying and validating internal tools that have a GxP impact.
• Assist in scoping validation efforts based on a corporate risk management approach.
• Help project teams define appropriate computerized systems validation strategies, including testing approaches and identifying appropriate objective evidence.
• Review and approve test executions performed by the Software Test Analysts during study validation activities.
• Develop, review, and/or approve Validation Plans and Reports.
• Maintain awareness of data management, validation, and data integrity needs in a GCP regulated environment.
• Participate in audits as a CSV subject matter expert. Assist in the training of CSV requirements
• Assist in the development and maintenance of validation-related procedures and deliverables in: Quality
• Evaluate CAPAs to identify areas of improvement for validation.
• Report regularly to Quality management on the validation efforts and deliverables.
• Assist other departments with tasks as appropriate.