Automation Validation Engineer

We are looking for a detail-oriented and technically skilled Automation Validation Engineer to lead the development, execution, and documentation of validation protocols for automated systems. In this fully remote role, you will ensure that automation tools and platforms meet regulatory, functional, and performance requirements, particularly in GxP-compliant or regulated environments. The ideal candidate has experience in automation systems validation, testing frameworks, and industry standards.

Key Responsibilities:

Develop and execute validation plans (IQ/OQ/PQ) for automated systems and software

Create and maintain documentation for validation protocols, test scripts, and reports

Collaborate with engineering, QA, and regulatory teams to ensure compliance with industry standards (e.g., FDA 21 CFR Part 11, GAMP 5)

Support system upgrades, change controls, and risk assessments

Troubleshoot validation issues and recommend corrective actions

Qualifications:

Bachelors degree in Engineering, Computer Science, Life Sciences, or related field

12+ years of experience in automation or software validation (preferably in regulated industries)

Strong knowledge of validation methodologies, test automation tools, and quality systems

Familiarity with GxP, FDA, ISO, or similar regulatory environments

Excellent analytical, communication, and documentation skills