Validation Engineer

Requirements:

• Minimum 7 to 9 years of experience in software testing/validation in a regulated environment.
• Ability to successfully manage multiple tasks and timelines.
• Ability to effectively liaise with project team members and other teams/departments, on-site and remotely.
• Ability to perform and coordinate activities required to bring/maintain systems to a validated state.
• In-depth knowledge of Software Development Life Cycle and its major phases.
• Proven experience with testing and validation deliverables such as Test/Validation Plan, Test Script Preparation/Execution/Review, Defect Management, Traceability Matrix, and Validation Summary Report is required.
• Proven experience in different types of testing, including but not limited to Black Box Testing, Graphical User Interface (GUI) Testing, System Testing (OQ), User Acceptance Testing (PQ), Functional Testing, and Regression Testing.
• Proven experience in testing applications developed in different programming languages and tools (i.e. Java, .Net, Oracle, MySQL, C++) is preferred.
• Proven experience with automated testing, preferably the Katalon tool, is required.
• Strong knowledge of regulatory guidelines on computerized systems, 21 CFR Part 11, Annex 11, and/or GAMP 5.
• Understanding of SQL and database concepts is preferred.
• Experience in Test Automation Tools or Application Lifecycle Management is preferred.
• Strong organizational and problem-solving skills for tasks and functions related to testing and validation of applications.
• Strong verbal and written communication skills.

Skills

21 CFR Part 11, Annex 11, GAMP, QA, Testing, Validation