Validation Engineer
Validation Engineer ensures software systems meet quality standards and regulatory requirements by planning/executing validation activities, authoring documentation, performing testing, and supporting audits in regulated environments. Requires bachelor's degree and QA experience in quality-focused settings.
About the job
Key Responsibilities
- Plan, execute, and maintain software validation activities in accordance with company procedures and applicable regulations (e.g., GxP, FDA, ISO).
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- Experience validating SaaS or cloud-based applications.
- Familiarity with GxP, 21 CFR Part 11, ISO 9001, or similar regulatory frameworks.
- Experience working with cross-functional teams in a fast-paced product environment.
- Prior experience supporting customer or internal audits.
Skills
Software Testing, Agile, SDLC, Gxp, 21 Cfr Part 11, Iso 9001, Validation Documentation, Risk Assessment, Test Protocols, Traceability Matrices, Functional Testing, Integration Testing, Regression Testing, User Acceptance Testing, Change Control
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