Immediate need of Senior Validation Engineer at Pomona, CA (Onsite Role) at Pomona, California, USA |
Email: [email protected] |
From: Syed Zameer Ahmed, Cygnus Professionals [email protected] Reply to: [email protected] Job Title: Senior Validation Engineer Location: Pomona, CA (Onsite Role) Duration: Long-term Contract Job Description: 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) 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 equipment's and software-based systems. If you are interested, please share me a copy of your resume along with following details ASAP. Required Details: Full Name: Current Location: Expected Rate: Work Authorization: Best Regards, Syed Zameer Ahmed E: [email protected] Keywords: California Immediate need of Senior Validation Engineer at Pomona, CA (Onsite Role) [email protected] |
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Fri Dec 06 01:21:00 UTC 2024 |