Senior Validation Engineer
Senior Validation Engineer
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1 Vacancy
Job Description
Title: Senior Validation Engineer
Location: Pomona CA
1494766BR
- 6 to 8 years of NonProduct Validation engineer with Manufacturing background (Medical devices or Diagnostics)
- NonProduct 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 softwarebased systems.
Employment Type
Full Time
