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CSV Engineer
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- CSV EngineerBoston/Rhode Island
- Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.
- Author and develop SOP and VMP for computer system validation for manufacturing equipment.
- Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.
- Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
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