CSV Engineer
4 weeks ago
- Minimum 7 years in CSV required.
- Experience in Validation and Testing (UAT, Regression Testing)
- Experience in leading application profile, operational requirements, business process and other project knowledge, as required, to provide the Services Experience creating detailed reports
- The deliverables will be created in Pharmaceutical SDLC template format, based on inputs from R&OA team: Compliance Plan Compliance Analysis User Requirement / User Story Business Process Analysis Configuration Document Functional Design Specifications UAT Protocol UAT Script Pre/Post Execution UAT Summary Report SIT Protocol (If Applicable) SIT Script Pre/Post Execution (If Applicable) SIT Summary Report (If Applicable) Data Conversion Plan, Protocol, Summary reports Traceability Matrix Change Control Compliance Summary Report
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CSV Engineer
5 days ago
Raritan, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: 7+ years of experience in Computer System Validation. Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams....
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CSV Engineer
1 month ago
Raritan, United States eTeam Full timeMinimum 7 years in CSV required. Experience in Validation and Testing (UAT, Regression Testing) Experience in leading application profile, operational requirements, business process and other project knowledge, as required, to provide the Services Experience creating detailed reports The deliverables will be created in Pharmaceutical SDLC template...
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Computer Systems Validation Engineer
2 weeks ago
Raritan, United States Cynet Systems Full timeJob Description: Pay Range $55hr - $62hr Responsibilities: 7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required. Working Knowledge of regulations: 21 CFR Part 11 and Annex 11. Understanding of quality risk-management concepts (ICH...
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Technical Equipment Specialist
7 days ago
Raritan, United States Legend Biotech US Full timeCompany Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...