Validation Analyst

Overview

This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Standard Office Hours (40/wk)

Office

Serves as Validation Support for new releases and modifications to applications throughout the computer system lifecycle. Prepares Master Validation Plans, Test Cases and Validation Summary Reports. Reviews change controls associated with the validated systems per SOP. Reviews PQ and change control documentation with the Application Manager per SOP. Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.

Updates test scripts where required based on requirement changes or upgrades in application functionality. Ensures test scripts accurately to produce objective evidence that the computer system consistently performs its intended functions accurately and reliably proving the software functions accurately. Creates, updates, and manages data within the testing environment, sufficient to accurately test software functionality. Performs periodic reviews of GxP systems to ensure system remains in a validated state.

Presents change controls and documentation to computer system validation committees as needed to obtain review and approvals. Provides ongoing business support to users during the implementation and continued use of validated platforms, ensuring that appropriate training, support and maintenance is provided.

• Serves as Validation Support for new releases and modifications to applications throughout the computer system lifecycle.
• Prepares Master Validation Plans, Test Cases and Validation Summary Reports.
• Reviews change controls associated with the validated systems per SOP.
• Reviews PQ and change control documentation with the Application Manager per SOP.
• Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.
• Updates test scripts where required based on requirement changes or upgrades in application functionality.
• Ensures test scripts accurately produce objective evidence that the computer system consistently performs its intended functions accurately and reliably proving the software functions accurately.
• Creates, updates, and manages data within the testing environment, sufficient to accurately test software functionality.
• Performs periodic reviews of GxP systems to ensure the system remains in a validated state.
• Presents change controls and documentation to computer system validation committees as needed to obtain review and approvals.
• Provides ongoing business support to users during the implementation and continued use of validated platforms, ensuring that appropriate training, support and maintenance is provided.