- Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability.
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CSV Engineer
1 week ago
Smart Bot Systems Somerville, United StatesJob Description · Job DescriptionHope you are doing well. · Please go through the job description. If you are fine, please share your updated resume. · Role: CSV Engineer · Location: Raritan, NJ (Hybrid) · Type: Contract · Job Description: · Roles and Responsibilities · 7+ year ...
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CSV Engineer
5 days ago
Novozen Healthcare LLC Raritan, United StatesRole: 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 C ...
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CSV Engineer
23 hours ago
Novozen Healthcare LLC Raritan, United StatesRole: 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 CF ...
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CSV Engineer
5 days ago
Smart Bot Systems Somerville, United StatesJob Description · Job Description · Hope you are doing well. · Please go through the job description. If you are fine, please share your updated resume. · Role: · CSV Engineer · Location: Raritan, NJ (Hybrid) · Type: Contract · Job Description: · Roles and Responsibilities · ...
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CSV Engineer
6 days ago
eTeam Raritan, United StatesMinimum 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 detail ...
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CSV Engineer
1 week ago
Katalyst Healthcares & Life Sciences South Plainfield, United States OTHERRoles & Responsibilities: · Authors, executes and/or reviews validation documents such as validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations for Computer and IT systems. · Expertise i ...
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Sr. Validation Engineer(CSV)
1 week ago
Katalyst Healthcares and Life Sciences Princeton, United StatesResponsibilities : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · Should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP ...
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Lead, Emerging Technologies
13 hours ago
Johnson & Johnson Raritan, United StatesJohnson & 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 ...
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Validation Engineering
1 week ago
BuildSubmarines Raritan, NJ, United StatesJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Equipment/Computer System Validation Specialist II-CAR-T Manufacturing. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world ...
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Technical Equipment Specialist
1 week ago
Legend Biotech US Raritan, United StatesCompany 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 ...
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BuildSubmarines Raritan, NJ, United StatesJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Equipment/Computer System Validation Specialist II-CAR-T Manufacturing. This position will be located in Raritan, NJ. · At the Janssen Pharmaceutical Companies of Jo ...
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Johnson & Johnson Raritan, United States Full timeJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Equipment/Computer System Validation Specialist II-CAR-T Manufacturing. This position will be located in Raritan, NJ. · At the Janssen Pharmaceutical Companies of Jo ...
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Computer Systems Validation Specialist
1 week ago
LabVantage Somerset, United StatesA.Job Description ObjectiveLabVantage Professional Services (PSO) are expanding their team to provide an increased level of Computer Systems Validation (CSV) services and solutions, to address growing customer needs. As a key member of the LabVantage PSO team, the LIMS CSV Specia ...
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Validation Engineer/Specialist
1 week ago
IPS-Integrated Project Services, LLC Somerset, United StatesJob Description: · At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer/Specialist to join our talented team at our office located ...
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Associate Director, Manufacturing Systems IT
5 days ago
Legend Biotech US Somerset, United StatesCompany InformationLegend 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 aut ...
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Engineer III, CQV
1 week ago
IPS-Integrated Project Services, LLC Somerset, United StatesJob Description: · At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. · In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, co ...
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Associate Director, Manufacturing Systems IT
10 hours ago
Legend Biotech US Somerset, United StatesCompany 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 ...
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Solutions Architect
1 week ago
Saxon Global New Brunswick, United StatesJob Description · Roles and Responsibilities: · Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for Client Global Regulatory Affairs · Drive alignment to Enterpr ...
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Validation Engineer IV
1 week ago
Katalyst HealthCares & Life Sciences South Plainfield, United States FreelanceResponsibilities: · Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cle ...
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Solutions Architect
2 weeks ago
Career Techniques Inc. Princeton, United StatesRoles and Responsibilities: · Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for Client Global Regulatory Affairs · Drive alignment to Enterprise and pharmaceutic ...
CSV Engineer - Raritan, NJ, United States - Katalyst Healthcares & Life Sciences
Description
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.
ReviewsPerforms 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.
