Validation Support Engineer - STAFTONIC LLC : Job Details

Validation Support Engineer

STAFTONIC LLC

Job Location : Albany,GA, USA

Posted on : 2025-06-11T02:20:23Z

Job Description :
Title: Validation Support EngineerIs your CV ready If so, and you are confident this is the role for you, make sure to apply asap.Location: GeorgiaLong Term ContractKey Responsibilities:Develop/update Master Validation Plans (MVPs) and individual Validation Plans (VPs)Conduct GxP risk assessmentsAuthor and execute IQ/OQ/PQ protocolsMaintain Requirements Traceability Matrices (RTMs)Manage deviations, support root cause analysis and CAPAsPrepare Validation Summary Reports (VSRs)Ensure compliance with cGMP, 21 CFR Part 11/210/211/820, and internal standardsKey Deliverables:Approved VPs, executed IQ/OQ/PQ protocolsCompleted RTMs and VSRsDeviation reports (if applicable)Contributions to QMS documentationQualifications:Strong knowledge of CSV (GAMP5), FDA regulationsProven experience with PLC validation (Beckhoff TwinCAT a strong plus)Ability to produce high-quality validation documentation and ensure regulatory compliance
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