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Automation Validation Engineer

Company: Insight Global
Location: wilson
Posted on: May 3, 2021

Job Description:

Looking for an automation validation engineer to join a team in Wilson, NC. This candidate will be responsible for developing and executing Computerized System Validation (CSV) deliverables for control systems for production equipment including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports. CSV will be specific to automated process equipment and interfaces. Minimum Requirements Understanding and experience with CSV regulations and guidelines such as FDA; cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5. Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC) Knowledge, familiarity and exposure to industrial control systems (PCS, Siemens PLC, or related), including related configuration/programming. Prefer five (5)+ years related work experience including strong knowledge and hands-on experience of computer system validation (CSV) activities in the regulated industries. Strong technical writing skills

Keywords: Insight Global, Wilson , Automation Validation Engineer, Other , wilson, North Carolina

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