CSV Engineer

3 weeks 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 validation of GxP applications and is able to perform document/process Compliance Analysis. Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology. Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability. Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements. Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement. Ensures pre-executed test protocol has the necessary test data requirements to run the tests. Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process. Able to author Validation Plan and compile Validation Summary Report and generates RTM. Reviews and ensures that the Operational Procedure for the application is ready. Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM.

  • CSV Engineer

    2 days ago

    Raritan, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: 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

    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...

  • CSV Engineer

    1 month 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...

  • Computer Systems Validation Engineer

    1 week ago

    Raritan, United States Cynet Systems Full time

    Job 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...

  • Staff Engineer

    4 days ago

    Titusville, NJ, United States Piper Companies Full time

    Piper Companies is currently seeking a ECQ Engineer for an opportunity in Titusville, New Jersey (NJ), to join a global pharmaceutical company.   Responsibilities of the ECQ Engineer Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products Develop, execute, and document equipment...

  • ECQ Engineer

    4 days ago

    Titusville, NJ, United States Piper Companies Full time

    Piper Companies is currently seeking a ECQ Engineer for an opportunity in Titusville, New Jersey (NJ), to join a global pharmaceutical company.   Responsibilities of the ECQ Engineer Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products Develop, execute, and document equipment...

  • ECQ Engineer

    5 days ago

    Titusville, NJ, US Piper Companies Full time

    Piper Companies is currently seeking a ECQ Engineer for an opportunity in Titusville, New Jersey (NJ), to join a global pharmaceutical company. Responsibilities of the ECQ EngineerMaintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical productsDevelop, execute, and document equipment qualification...

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    4 weeks ago

    SUMMIT, NJ, United States Axelon Full time

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    3 days ago

    Raritan, United States Legend Biotech US Full time

    Company 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)...