• Sr Business Analyst, Manufacturing

    Cordis (Irvine, CA)
    …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... (PLM). You'll map business processes end-to-end, translate them into system requirements, and lead continuous improvement initiatives that boost productivity,… more
    Cordis (07/30/25)
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  • Sr. Associate IS Business System Analyst…

    Amgen (Thousand Oaks, CA)
    …key IS domains and layers + Understanding of FDA regulations governing computer system validation and operation + Familiarity with security requirements ... and deployment + Develop and maintain System Architecture models (eg System Interaction diagrams) and reference implementations within systems of record (eg… more
    Amgen (09/27/25)
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  • Senior Compliance/ Validation Engineer

    Genentech (Oceanside, CA)
    …ServiceNow ticketing system . + Any other duties as assigned/required for compliance/ validation of ITOT systems /processes. **Who you are:** + Has business ... pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations...you will have responsibilities for IT OT compliance and Validation ensure compliance for all IT Systems .… more
    Genentech (09/09/25)
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  • Senior Analyst, Business Systems , IT,…

    Edwards Lifesciences (Irvine, CA)
    …+ Experience with FDA guidelines for Software Quality and Systems Validation required + Experience with Good Manufacturing/Good Documentation Practices ... by Leadership **What you'll need:** + Bachelor's degree in computer science or related field + 4 years of...with FDA guidelines for Software Quality and Systems Validation is a plus + Substantial… more
    Edwards Lifesciences (09/22/25)
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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 (08/13/25)
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  • Sr Embedded Software Engineer (Sr. Java Engineer)

    Abbott (San Diego, CA)
    …role oversees the design, development, and validation of software for embedded systems , ensuring compliance with FDA requirements. They play a crucial role ... problems of moderate scope. Participate in software development, verification, and validation activities under guidance Adhere to FDA -compliant Design Control… more
    Abbott (07/30/25)
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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 (09/18/25)
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  • Assistant Director, GMP Quality Systems

    Kelly Services (Carlsbad, CA)
    …is instrumental in leading both internal and external audit programs with an emphasis on computer system validation (CSV) and data integrity audits. As a key ... & Clinical is seeking an Assistant Director, GMP Quality Systems for a direct hire opportunity with one of...+ Thorough understanding of domestic and international GMP regulations ( FDA , Eudralex, Health Canada, ICH, MHRA, MHLW, etc.). +… more
    Kelly Services (09/30/25)
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  • Senior Quality Systems Manager, Design…

    Medtronic (Santa Rosa, CA)
    …connected, compassionate world. **A Day in the Life** The Senior Quality Systems Manager drives the evolution of Medtronic's product development processes to set ... insights are incorporated into early design phases. + Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts… more
    Medtronic (09/25/25)
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  • Software Quality Engineer II

    Abbott (Sylmar, CA)
    …same. + Work with R&D and Manufacturing Engineering in the completion of system /software requirements and other verification and validation processes. + Create ... and execute or direct software validation protocols traceable to system /software requirements. Execute and support on-time completion of Quality Engineering… more
    Abbott (08/20/25)
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