דרושים 21137 - Computer System Validation (CSV) Engineer בנתניה

Job description:

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 PlansUser Requirements Specifications (URS)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.

Profile description:

Requirements:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
• 2–5 years of hands-on experience in Computer System Validation within regulated industries
• Practical knowledge of GxP regulations and guidelines including:FDA 21 CFR Part 11EU GMP Annex 11GAMP 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

We offer:

Why should you join us?

• 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