CSV Engineer
1 week ago
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.
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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...
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CSV Engineer
3 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...
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Technical Equipment Specialist
3 weeks 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)...
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Lead, Emerging Technologies
3 weeks ago
Raritan, United States Johnson & Johnson Full timeJohnson & Johnson is recruiting for a Lead, Emerging Technologies, Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States. This position may require up to 20% travel. - Per our J&J Flex Policy, the expectation for this position is to work in the nearest Johnson and Johnson office 3-4 days per week and work from...
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Technical Equipment Specialist
4 weeks 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)...