CSV Engineer

4 months ago

Austin, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities & Requirements: Previously worked in medical device / pharmaceutical industries. Minimum years of experience in Computer Systems Validation. Prior experience working on the validation of Manufacturing Execution systems (MES), ERP systems, custom tools, COTS applications. ISO , FDA CFR , CFR Part . CAPA, Non-conformances and change management. Experienced in Software Risk assessment. Having prior experience with CSA is a plus. Must be able to work in fast paced environments within a team and independently. CAT (Category ) software includes software used for process control and monitoring that is critical to product quality. It requires thorough testing and validation to ensure its reliability and effectiveness. CAT (Category ) software includes software used for non-critical purposes, such as utilities and supporting systems. While still important, CAT software may not require the same level of validation as CAT software .

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