Senior Validation Engineer

Job in Frisco, Collin County, Texas, 75034, USA

Listing for: TechDigital Group

Full Time position
Listed on 2026-10-23

Job specializations:

Engineering
Quality Engineering, Validation Engineer, Systems Engineer

Salary/Wage Range or Industry Benchmark: 120000 - 160000 USD Yearly USD 120000.00 160000.00 YEAR

Job Responsibilities:

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

Non-Product software validation for Manufacturing Equipments 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).

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 requirement and provide testing strategy, implementing technical & procedural controls as part of mitigation.

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

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