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South Plainfield

    Validation Engineer - South Plainfield, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences South Plainfield, United States

    3 weeks ago

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    Description
    Roles & Responsibilities:
    • Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations.
    • Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor and record temperature, ensure that all validation functions and related capabilities are fully operational.
    • Responsible to prepare/implement Validation Master Plan and Protocols as well as Technical Reports to comply with current regulations.
    • Responsible to develop Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and test standards.
    • Responsible to document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes.
    • Responsible to develop and review Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
    • Responsible for Qualification and validation of analytical instrument laboratory equipment.
    • Responsible to perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in the pharmaceutical industry in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
    • Responsible to execute documents adhering to the governing SOP's, Protocols, Project plans, & cGMP.
    • Responsible to write and execute the official test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accurately.
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