Validation Engineer

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.