# Validation Engineer

**Company:** [Uncountable](https://hotfix.jobs/companies/uncountable)
**Location:** Remote
**Role:** QA Engineering
**Salary:** $90k – $111k/yr
**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
**Posted:** 2026-02-10

> 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.

## Job Description

## 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.

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