CSV Engineer

3 weeks ago

Raritan, United States eTeam Full time
  • 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

  • CSV Engineer

    7 days ago

    Raritan, United States Novozen Healthcare LLC Full time

    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 11Understanding of quality risk-management concepts (ICH Q9) and adept...

  • CSV Engineer

    7 days ago

    Raritan, United States Novozen Healthcare LLC Full time

    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 11Understanding of quality risk-management concepts (ICH Q9) and adept...

  • CSV Engineer

    6 days ago

    Raritan, United States Novozen Healthcare LLC Full time

    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...

  • CSV Engineer

    6 days ago

    Raritan, United States Novozen Healthcare LLC Full time

    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 11Understanding of quality risk-management concepts (ICH Q9) and adept...

  • CSV Engineer

    1 week ago

    Raritan, United States eTeam Full time

    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...

  • CSV Engineer

    7 days ago

    Raritan, NJ, United States Katalyst Healthcares & Life Sciences Full time

    Responsibilities: 3+ years' Experience in Validating MES or Manufacturing an Lab systems. Experienced in CSV activities in Manufacturing related applications like SAP Systems, MES systems or Lab related systems in the manufacturing space. Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end...