Validation Engineer

Computerized Systems Validation (CSV) Engineer | Karmiel, Israel

An innovative Israeli biopharmaceutical company is looking for a Computerized Systems Validation (CSV) Engineer to join a professional team in a dynamic, technologically advanced environment.

Key Responsibilities:

✔ Lead and manage Computerized Systems Validation (CSV) projects from requirements definition through implementation and qualification.

✔ Plan and execute software testing activities, document results, and manage deviations and issue resolution processes.

✔ Prepare, review, and approve validation documentation, including URS, validation protocols, risk assessments, change controls, and technical specifications.

✔ Ensure compliance with applicable regulatory requirements and industry standards, including GAMP 5, Annex 11/15, and 21 CFR Part 11.

✔ Qualify and validate computerized systems used in manufacturing, laboratories, and enterprise environments.

✔ Conduct supplier assessments and audits for software and computerized systems.

✔ Collaborate cross-functionally with end users, engineering, automation, IT, and Quality Assurance teams.

Requirements:

✔ B.Sc. in Industrial Engineering & Management (Information Systems specialization), Information Systems, Computer Science, or a related field.

✔ Experience in Computerized Systems Validation within the pharmaceutical industry – a significant advantage.

✔ Familiarity with software development and testing methodologies – an advantage.

✔ Knowledge of computerized systems, databases, automation, control systems, and communication networks – an advantage.

✔ Fluent Hebrew and English – mandatory.

✔ Proficiency in Microsoft Office applications – mandatory.

📩 Interested in joining a cutting-edge biopharmaceutical company and contributing to innovative healthcare solutions? Feel free to apply or reach out directly.