• Computer Systems Validation

    Unither Pharmaceuticals (Rochester, NY)
    …Specifications, Functional and Design Specifications. If completed by an external company, the computer systems validation ( CSV ) specialist will be ... Computer Systems Validation Specialist... Computer Systems Validation Specialist Who we are?...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and… more
    Unither Pharmaceuticals (05/08/25)
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  • Senior QA Validation Specialist…

    Curia (Rensselaer, NY)
    …for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer will provide ... Senior QA Validation Specialist - CSV Systems...functional areas across the organization to maintain and improve computer system validation processes to… more
    Curia (06/20/25)
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  • Senior Director IT Quality Assurance & Compliance

    Regeneron Pharmaceuticals (Sleepy Hollow, NY)
    …solutions to maintain compliance. * Applying practical experience of IT Risk Management Methodology to Computer Systems Validation ( CSV ) and Computer ... SOX, and other compliance requirements, across all our IT systems and processes. * Ensure policies, procedures, and practices...standards and manage the evaluation of tools to support system testing. * Oversee the budget and resources, ensuring… more
    Regeneron Pharmaceuticals (06/17/25)
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  • Validation Specialist - Computer

    Kedrion Biopharma (Melville, NY)
    …audit trails, access controls, data migration, and backup._ + _Own and maintain system validation procedures and documentation across the site._ + _Partner with ... _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play...GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing… more
    Kedrion Biopharma (05/06/25)
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  • Senior Validation Engineer, QRM

    Cornerstone onDemand (New York, NY)
    …in a Technology company that supplies systems to customers who validate computer systems based on regulatory requirements and intended use + Demonstrated ... Validation ) lifecycle for Cornerstone's validated SaaS Learning Management System (LMS), which is deployed to customers in heavily...have ** + Bachelor's or Master's degree in Information Systems , Computer Science, or a related technical… more
    Cornerstone onDemand (06/26/25)
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  • Principal Business Analyst - Process Analytics

    Regeneron Pharmaceuticals (East Greenbush, NY)
    …architecture, collating data, and preparing data sets in support of testing and validation activities. + Troubleshooting computer systems and developing ... management. + Generating design, requirements, and testing documentation in support of validation activities. Reviewing CSV documentation and giving guidance to… more
    Regeneron Pharmaceuticals (07/01/25)
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  • Lead Consultant - MES OpCenter - Remote

    Cognizant (Albany, NY)
    …management and delivery with benefits delivered as committed required. + Experience in GxP systems , Computer System Validation , and consistent track ... resources to design, develop, configure and test MES (Manufacturing Execution Systems ) solutions. They will be directly responsibility for leading resources… more
    Cognizant (06/04/25)
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  • API Process Improvement Analyst II, Insurance

    Guardian Life (Albany, NY)
    …existing structure to Guardian Standards to ensure a seamless data exchange across systems to meet vendor needs when connections are not compatible with various ... products, policies, Security and Monitoring a plus + Strong computer skills: MS Excel, Postman + Working with Benefit...files to create output in various formats: 834, JSON, CSV + Exhibited flexibility in handling multiple tasks, responding… more
    Guardian Life (06/05/25)
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