Uncountable Inc.
The Unified Laboratory Informatics & Data Management Platform for Modern R&D Organizations
Validation Engineer
Location
United States
Posted
17 days ago
Salary
$90K - $111K / year
Bachelor DegreeEnglishSDLC
Job Description
• 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.
Job Requirements
- 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.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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