Computer System Validation Engineer

Computer System Validation Engineer at Qualitest

Qualitest is the world’s leading AI-powered Quality Engineering company. With over 8,000 experts worldwide and 1,500 in Israel, we partner with top global brands to deliver smarter, faster, and more reliable technology solutions.

For five consecutive years, Qualitest has been recognized as one of Israel’s Top 100 Best Places to Work, showcasing our dedication to providing a stable, supportive, and growth-oriented workplace.

About the Role

We are currently seeking a QA Engineer – Computer System Validation Engineer based in Netanya. This role will be pivotal in supporting validation activities for computerized systems utilized within regulated Life Sciences environments.

Responsibilities

• Ensure computer systems comply with applicable regulations and standards throughout their full lifecycle, including implementation, upgrades, and ongoing operation.
• Plan, execute, and maintain Computer System Validation (CSV) activities in accordance with industry best practices.
• Execute CSV activities in compliance with regulatory requirements such as GxP, FDA 21 CFR Part 11, and EU GMP Annex 11.
• Participate in system lifecycle activities including implementation, upgrades, migrations, and system decommissioning.
• Prepare, review, and maintain validation documentation, including implementation, upgrades, migrations, and decommissioning.
• Prepare and review validation documentation including: Validation Plans, User Requirements Specifications (URS), and Risk Assessments (e.g., GAMP 5 based).
• Support risk-based validation approaches and leverage supplier documentation when applicable.
• Perform and support testing activities, including deviation handling and proper documentation.
• Collaborate closely with IT, Quality Assurance, business stakeholders, and external vendors to resolve validation-related issues.
• Maintain validation status during system operation through change control processes and periodic reviews.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
• 2–4 years of hands-on experience in Computer System Validation within regulated industries.
• Practical knowledge of GxP regulations and guidelines including: FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
• Familiarity with risk-based validation methodologies.
• Strong documentation skills with high attention to detail.
• Ability to work independently as well as in cross-functional teams.
• Good written and verbal communication skills in English.

Why Join Qualitest?

• Grow your career in a stable, innovative environment.
• Collaborate closely with clients to deliver smart, high-quality solutions.
• Make an impact in a dynamic, learning-driven environment.
• Be part of a human, value-driven organization that cares.

Key skills/competency

• Computer System Validation (CSV)
• GxP Regulations
• FDA 21 CFR Part 11
• EU GMP Annex 11
• GAMP 5
• Validation Documentation
• Risk Assessments
• System Lifecycle Management
• Change Control
• Quality Assurance