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Senior Systems Engineer
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- Develop and implement data integrity strategies including data protection, backups and disaster recovery.
- Oversee the installation activities for each instrument type, including guiding the Non-GxP IT team in setting up computer workstations, ensuring data security and permissions, configuring software, and more according to the Standards for GxP Computerized Systems.
- Collaborate with business owners and validation to create and edit key SDLC deliverables, including Change Control Records, User Requirements Specifications, Configuration Specifications, Risk Assessments, and IQ, OQ, PQ Test Cases.
- Create Decommissioning/Data Archiving plan and procedures and support decommissioning/data Migration activities in GxP CS Validation Life Cycle.
- Assist with and provide input as SME and Technical system owner (TSO) for the other documents in the validation process, such as user and functional requirements, risk assessment, operational qualification related to software functions, etc.
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