CSV Engineer
3 weeks ago
Role: CSV Engineer
Location: Raritan, NJ
Roles and 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 Q9) and adept in applying Good Manufacturing Practices principles
Experience in systems validation and quality frameworks and risk based quality approach
Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensures compliance with regulatory and client requirements.
Experience in executing change control and document management
Knowledge of GAMP5 and Quality Systems
Experience on decommission, Archiving and Data Integrity (ALOCA+)
Prior experience in using of tools like qtest, Document Management system (EDMS), ServiceNow and JIRA
Experience in computer systems validation, GXP regulatory knowledge with good documentation methods and CSA approaches and risk-based validation required.
Test automation tools and methods, authoring and/or reviewing validation deliverables such as Compliance Plan, Summary Report, Test Protocols, Test Scripts, Requirements and Trace Matrix is required.
Experience working in Agile methodology and tools is required.
-
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....
-
CSV Engineer
4 weeks 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...
-
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...
-
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...
-
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)...