Uncountable Inc. - Validation Engineer
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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. • 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.
Responsibilities
• 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.
Benefits
• Upload your resume here to autofill key application fields. • Drop your resume here! • Parsing your resume. Autofilling key fields... • Please provide a phone number that can be used to contact you about this position. • or drag and drop here • What is your current location for the purposes of understanding relocation needs and interview scheduling? • What company and position are you currently in? • (OPTIONAL) Include any additional information that should be considered in the application.
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