Validation Engineer

We are seeking a Validation Engineer to lead test case development and execution for factory assemblies and IT system enhancements, ensuring compliance with quality and regulatory standards.

Responsibilities

• Develop and execute validation test cases and plans for factory and IT systems.
• Lead design reviews and provide guidance to equipment suppliers from design to site acceptance.
• Collaborate with molding, automation, and software engineering teams to resolve validation issues.
• Partner with the quality team to develop validation protocols, reports, and approvals.
• Perform computer system validation and support system enhancements.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Experience in validation engineering and test case development.
• Knowledge of molding, automation, software engineering, and quality systems.
• Familiarity with computer system validation (CSV) and regulatory requirements (ISO, FDA, GMP).

Preferred

• Experience in regulated industries (pharmaceutical, medical device).
• Proficiency in tools like Jira, SAP, or similar.

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