Validation Engineer
Core
Ensuring software systems meet internal quality standards and regulatory requirements by planning, executing, and maintaining validation activities throughout the software development lifecycle.
Role type
Validation Engineer (Software Quality & Compliance)
Builds
Validated software systems for R&D teams in regulated and non-regulated industries
Domain
Software Engineering / Regulatory Compliance (GxP, FDA, ISO, FedRamp)
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software validation planning and execution, regulatory compliance knowledge (GxP, FDA, ISO, FedRamp), validation documentation authoring, test protocol design, risk assessment, change control impact analysis, audit support, process improvement
Preferred skills
SaaS or cloud-based application validation, 21 CFR Part 11 experience, cross-functional team collaboration in fast-paced environments, internal or customer audit support
Technologies
SaaS platforms, cloud-based applications
Responsibilities
Plan, execute, and maintain software validation activities; Author and maintain validation documentation (plans, risk assessments, test protocols, reports, traceability matrices); Review system requirements and user stories for testability; Execute and review functional, integration, regression, and UAT; Support change control activities; Collaborate with Engineering and Product to identify risks; Participate in audits and inspections; Continuously improve validation processes and tools
Full job description
About Uncountable
Uncountable builds software that helps R&D teams manage data, workflows, and experimentation at scale. Our platform is used by scientific and engineering teams across regulated and non-regulated industries, and quality, reliability, and compliance are core to how we build and ship product.
Role Overview
The Validation Engineer is responsible for ensuring that Uncountable’s software systems meet internal quality standards and applicable regulatory requirements. This role partners closely with Engineering, Product, and Quality to design, execute, and maintain validation activities throughout the software development lifecycle.
Currently, we do not sponsor employment visas for this position. Applicants must be legally authorized to work in the US without current or future sponsorship.
Key Responsibilities
• Plan, execute, and maintain software validation activities in accordance with company procedures and applicable regulations (e.g., FedRamp, 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.
Required Qualifications
• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field (or equivalent practical experience).
• 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.
