• Senior Validation Specialist

    Regeneron Pharmaceuticals (Cambridge, MA)
    We are seeking a highly skilled, self-motivated ** Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... Part 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
    Regeneron Pharmaceuticals (07/26/25)
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  • US Capital Project Computer Systems…

    Merck (Rahway, NJ)
    **Job Description** The Digital Foundational Services, US Capital Project CSV, Senior Specialist role is charged with the administration of regulatory compliance ... + Liaise with product teams/technology functions and act as an SME on computer validation for capital projects in the region. + Provision of ongoing … more
    Merck (08/08/25)
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  • Senior QA Validation

    Curia (Rensselaer, NY)
    Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer is an integral part of ... is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer will provide… more
    Curia (06/20/25)
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  • Senior Validation Specialist

    Catalent Pharma Solutions (St. Petersburg, FL)
    ** Senior Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... Within the Catalent network, we offer a broad range of integrated formulation. The ** Senior Validation Specialist ** with guidance from the Validation more
    Catalent Pharma Solutions (07/24/25)
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  • Senior Cleaning Validation

    Catalent Pharma Solutions (St. Petersburg, FL)
    ** Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... services to solve your most difficult development and manufacturing challenges The ** Senior Cleaning Validation Specialist ** position involves creating… more
    Catalent Pharma Solutions (06/18/25)
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  • Senior Specialist

    Lotte Biologics USA LLC (Syracuse, NY)
    …continuous innovation, to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key ... ensuring protocols and reports meet LOTTE BIOLOGICS standards. Reporting to the Senior Manager, Validation Services, you will manage and coordinate installation,… more
    Lotte Biologics USA LLC (07/28/25)
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  • Senior Specialist

    Lotte Biologics USA LLC (Syracuse, NY)
    …continuous innovation, to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key ... ensuring protocols and reports meet LOTTE BIOLOGICS standards. Reporting to the Senior Manager, Validation Services, you will manage and coordinate installation,… more
    Lotte Biologics USA LLC (07/14/25)
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  • Test & Validation Technician

    Legrand NA (Reno, NV)
    …Control Team in Reno, NV. Under general supervision of the Operations Engineering Senior Manager, the Test & Validation Technician will support the Operations ... procedures defined and implemented prior to new product release. The Test & Validation Technician is an entry level position that will ensure that all regulatory… more
    Legrand NA (07/09/25)
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  • Quality Systems Senior Specialist

    Integra LifeSciences (Princeton, NJ)
    …of care. As part of Integra's Business Systems Team, the Quality Systems Senior Specialist is a seasoned professional with complete and in-depth conceptual ... scripts, URS documents, FRS and Configuration Specification documentation following Integra's Computer System Validation and Change control process to maintain… more
    Integra LifeSciences (05/17/25)
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  • Senior MES PAS-X Specialist

    Capgemini (NY)
    **Title: Senior MES PAS-X Specialist /Engineer** **Location: Raritan NJ OR Remote** **Duration: Full Time** **Job Description:** As a Senior MES PAS-X MBR ... GMBR's on PAS-X V3 (V 3.1.8 or higher) + Validation and UAT of MBR's\GMR\ESP + Werum PAS-X Implementation:...on Werum PAS-X systems. + Bachelor's degree in engineering, Computer Science, or a related field. Masters degree is… more
    Capgemini (08/08/25)
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