• Validation Technician

    Actalent (Santa Ana, CA)
    …and assist in process development and troubleshooting. Responsibilities + Maintain the validation program for computer systems , facilities, equipment, and ... industry is preferred. + Familiarity with GMP procedures and requirements, including Quality Systems and cGMP requirements ( FDA , EU, ICH). + Ability to assess… more
    Actalent (06/24/25)
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  • Service Line Specialist (SPE) - Life Sciences…

    Cognizant (San Francisco, CA)
    …value chain, Products/ Platforms used. + Knowledge of FDA regulations for Computer system validation , Medical Device regulations, GAMP 5 + Knowledge ... of Test Automation, Understanding of Gen AI will be a plus. + Experience and proven track record of dealing with IT, business, C level executives. + Well-rounded consultant with the ability to cross-sell, up-sell across all functional areas. + Ability to… more
    Cognizant (06/16/25)
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  • Associate Director, GxP Systems

    Vera Therapeutics (Brisbane, CA)
    …gathering, configuration, testing, and deployment. * Partner with QA to develop and maintain Computer System Validation (CSV) documentation per GAMP5 and 21 ... Systems and will be responsible for leading the implementation, validation , and support of GxP-regulated systems to enable Quality, Regulatory,… more
    Vera Therapeutics (06/25/25)
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  • Staff Systems Verification Engineer

    Abbott (Pleasanton, CA)
    …related discipline + 8+ years of experience in a similar position, including system verification and validation , systems integration experience, software ... The Staff Systems Verification Engineer will be accountable for delivering system verification across the full CardioMEMS system in support of multiple… more
    Abbott (06/02/25)
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  • Systems Engineer I

    Abbott (Pleasanton, CA)
    …tests, and integrates components, disciplines, and products within the CardioMEMS HF System , including implantable sensors, external reader systems used by ... generation products, including requirements definition and management, design documentation, and system testing, verification, and validation . **What You'll Work… more
    Abbott (06/21/25)
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  • CSV Automation Specialist

    VTI Life Sciences (San Diego, CA)
    …of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation ....Validation . + Must have experience working in an FDA -regulated environment. + Experience with Automation Equipment such as… more
    VTI Life Sciences (05/13/25)
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  • Sr. Manager, SAP Cgto Solutions Architect

    Gilead Sciences, Inc. (Santa Monica, CA)
    …CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP CGTO ... processes, ensuring seamless integration with SAP S/4HANA and other related systems (SFHC - upstream, MES, Robar/Bartender - downstream) and driving business… more
    Gilead Sciences, Inc. (06/03/25)
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  • Staff Engineer, Quality (New Products)

    Terumo Neuro (Aliso Viejo, CA)
    …method validation and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4. Proven experience in ... risk assessments and FMEAs. + Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal… more
    Terumo Neuro (06/19/25)
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  • Senior Software Quality Engineer

    Abbott (Sylmar, CA)
    …issues. + Validation : Create and execute or direct software validation protocols traceable to system /software requirements. + Change Management:Implement ... + Work with Design and Manufacturing Engineering in the completion of system /software requirements and other verification and validation processes. + Create… more
    Abbott (04/03/25)
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  • Embedded Software Engineer

    Abbott (Alameda, CA)
    …oversees the design, development, and validation of software for embedded systems , ensuring compliance with FDA requirements. They play a crucial role ... addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control… more
    Abbott (06/26/25)
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