• Laboratory Information Management System…

    NTT DATA North America (Highland Heights, KY)
    …Computer Science, or related discipline. Additional certifications in LIMS administration, Computer System Validation (CSV), GAMP 5, or Quality/Regulatory ... as FDA 21 CFR Part 11, GxP, GLP, GMP, and ISO guidelines. Oversee system validation activities, risk assessments, and periodic audits. System Enhancements… more
    NTT DATA North America (09/26/25)
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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 ... Test Scripts. + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must have experience working in an… more
    VTI Life Sciences (08/13/25)
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  • Engineer - Quality - FUME

    Lilly (Pleasant Prairie, WI)
    …+ Previous experience with C&Q and Validation oversight including automation and computer systems validation + Demonstrated knowledge and use of US, ... working with Global Facilities Delivery, Lilly project staff, Global Computer Systems QA, and selected service provider...certification from the American Society for Quality (ASQ) + Computer System Quality Assurance (CSQA) experience +… more
    Lilly (09/30/25)
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  • Systems Administrator

    Lilly (Branchburg, NJ)
    …software applications for system management, compliance, and data integrity Partners with Computer System Validation (CSV), IT, QC, and QA to ensure ... Assists in the selection, implementation, and maintenance of computerized systems . Authors and reviews computer system...management, testing, and Qualification, Validation of proposed systems + Provide lab management and system … more
    Lilly (09/10/25)
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  • Jt772 - Sr. Software Quality Engineer

    Quality Consulting Group (Juncos, PR)
    …tools, techniques, and methodologies. + Provides or directs verification and validation of software system requirements, traceability, and testability. + ... Organization and Communication skills + Technical writing knowledge + Knowledge of Process validation and Computer software validation (eg requirements flow… more
    Quality Consulting Group (08/28/25)
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  • MES System Engineer - Syncade…

    Lilly (Concord, NC)
    …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation (CSV) principles (eg, GAMP 5, 21 ... the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
    Lilly (08/19/25)
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  • Data Analytics Systems Engineer

    Lilly (Branchburg, NJ)
    …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and ... the pre- validation assessment of all cGXPsystems and dashboards, ensuring that all validation requirements have been met prior to system testing. + Enable… more
    Lilly (10/02/25)
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  • Exec Director, Head of Digital Quality

    Gilead Sciences, Inc. (Santa Monica, CA)
    …software development methodologies * Quality & Compliance Expertise: Mastery of GMP, quality systems , Computer Validation and Data Integrity * Digital ... Compliance * Oversee, Develop and maintain the Quality Management System (QMS) for digital health products and GxP computerized...GxP digital Compliance (CSV, Data Integrity etc.) * Oversee validation lifecycle for systems such as Veeva… more
    Gilead Sciences, Inc. (10/02/25)
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  • Scientist II or III - Analytical Chemist Metrology…

    Parexel (PA)
    …and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications -** ... or other specialized computerized systems ** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of… more
    Parexel (08/30/25)
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  • Principal, Quality Assurance, GMP

    West Pharmaceutical Services (Exton, PA)
    …expert guidance on regulatory and industry standards concerning data integrity, including computer system validation , audit trails, electronic signatures, ... and industry expectations in terms of data integrity requirements: computer system validation , audit trail,...of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378,… more
    West Pharmaceutical Services (08/24/25)
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