Automation Validation Engineer

R.W. Mercer Co.; Raleigh (NC); Remote; USD 80,000 - 120,000; Full time

Job summary

An innovative firm is seeking a detail-oriented Automation Validation Engineer for a fully remote role. This position focuses on leading the development and execution of validation protocols for automated systems in regulated environments. The ideal candidate will have extensive experience in automation validation, regulatory compliance, and testing frameworks. You will play a crucial role in ensuring that automation tools meet stringent performance and regulatory requirements. Join a forward-thinking company that values technical expertise and offers a dynamic work environment where your contributions can significantly impact the quality and compliance of automated systems.

Qualifications

• 12+ years of experience in automation or software validation.
• Strong knowledge of validation methodologies and quality systems.

Responsibilities

• Develop and execute validation plans for automated systems.
• Collaborate with teams to ensure compliance with industry standards.

Skills

Automation Systems Validation

Testing Frameworks

Regulatory Compliance (GxP, FDA)

Analytical Skills

Documentation Skills

Education

Bachelor's Degree in Engineering

Bachelor's Degree in Computer Science

Bachelor's Degree in Life Sciences

Tools

Test Automation Tools

Job description

Join to apply for the Automation Validation Engineer role at R.W. Mercer Co.

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:

1. Develop and execute validation plans (IQ/OQ/PQ) for automated systems and software
2. Create and maintain documentation for validation protocols, test scripts, and reports
3. Collaborate with engineering, QA, and regulatory teams to ensure compliance with industry standards (e.g., FDA 21 CFR Part 11, GAMP 5)
4. Support system upgrades, change controls, and risk assessments
5. Troubleshoot validation issues and recommend corrective actions

Qualifications:

1. Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
2. 12+ years of experience in automation or software validation (preferably in regulated industries)
3. Strong knowledge of validation methodologies, test automation tools, and quality systems
4. Familiarity with GxP, FDA, ISO, or similar regulatory environments
5. Excellent analytical, communication, and documentation skills