Validation Engineer
: Job Details :

Responsibilities:

• Functional requirement specification, function risk assessment, installation qualification, operational.

• Qualification, performance qualification, traceability matrix, project release notes, system certification summary).

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

• 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 Equipements 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.