| Senior Validation Engineer role in Pomona, CA - Contract - Onsite Project at Pomona, New York, USA |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1984849&uid= From: bala, Fisec [email protected] Reply to: [email protected] Senior Validation Engineer Pomona, CA Contract Onsite Project Requirement: 6 to 8 years of Non-Product Validation engineer with Manufacturing background (Medical devices or Diagnostics) Non-Product software validation for Manufacturing Equipment 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. Keywords: California Senior Validation Engineer role in Pomona, CA - Contract - Onsite Project [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1984849&uid= |
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| 12:40 AM 05-Dec-24 |