Plan, execute, and maintain software validation activities in accordance with company procedures and applicable regulations (e.g., GxP, FDA, ISO, as applicable).
Author and maintain validation documentation, including validation plans, risk assessments, test protocols, test reports, and traceability matrices.
Review system requirements, design specifications, and user stories to ensure they are testable and appropriately controlled.
Execute and/or review functional, integration, regression, and user acceptance testing.
Support change control activities by assessing validation impact and updating documentation as needed.
Collaborate with Engineering and Product to identify risks early and ensure quality is built into the development process.
Participate in audits and inspections by preparing documentation and supporting responses.
Continuously improve validation processes, templates, and tools to increase efficiency and scalability.

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field (or equivalent practical experience).
Experience in software validation, quality engineering, or QA in a regulated or quality-focused environment.
Familiarity with SDLC concepts, Agile development, and software testing methodologies.
Experience authoring and maintaining validation and quality documentation.
Strong attention to detail and ability to manage multiple validation activities in parallel.
Clear written and verbal communication skills.

Validation Engineer

Key skills