Validation Engineer - Katalyst Healthcares & Life Sciences

• Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP.

• Preparing trace matrix to ensure requirements are tested to meet the software intended use.

• Preparing risk assessment for functional requirements and providing testing. strategy, implementing technical & procedural controls as part of mitigation.

• Preparing SOP/Work instruction for equipment and software-based systems.

Requirements:

• 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics).

• Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements).

• Prepare, review functional requirements, design and testing documents.

• Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment, installation qualification, operational qualification, performance qualification, traceability matrix, project release notes, system certification summary).