Systems Test Engineer

Role & responsibilities

• Support the development of detailed User Requirement Specifications, Project Specifications, and Functional and Design Specifications as applicable.
• Responsible for developing detailed validation plans to cover the testing strategy, intended use of application, validation and functional risks, and the planned validation activities.
• Responsible for creating test cases and scripts to adequately verify that the software is performing as intended.
• Responsible for creating Requirements Traceability Matrixes to ensure that all requirements have been adequately tested.
• Responsible for developing detailed validation reports covering the results of the validation activities and any issues identified.
• Effectively manage the issue tracking system.
• Ensure that issues are documented and resolved in the issue tracking system in a timely manner.
• Responsible for ensuring that software applications are developed and deployed with the ability to comply with 21 CFR Part 11, Electronic Records; Electronic Signature and Annex 11: Computerized Systems, EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, GMP Medicinal Products for Human and Veterinary Use.
• Performs other departmental or study-related duties as assigned.

Preferred candidate profile