• Director, Quality - Digital Systems

    ThermoFisher Scientific (Indianapolis, IN)
    … of critical business systems . + Coordinate all aspects of the company's Computer System Validation ( CSV ) and global IT activities supporting ... committed to computer systems compliance and validation.... + Integrate Risk Management tools into a compliant Computer System and Automation Validation … more
    ThermoFisher Scientific (07/12/25)
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  • Advisor - Electronic Lab Systems…

    Lilly (Indianapolis, IN)
    …with customers, company, and quality priorities to support implementation objectives. + Participates in computer system validation ( CSV ), computer ... particularly those related to APIs. **Responsibilities:** The Electronic Laboratory Systems Advisor/Sr. Advisor oversees the implementation, validation , and… more
    Lilly (07/09/25)
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  • Automation Engineer - Global Serialization Program

    Lilly (Indianapolis, IN)
    …serialization strategy for packaging. + Experience with Good Manufacturing Practices (GMP) and Computer System Validation ( CSV ) regulations, will be ... Engineer - GSP (Global Serialization Program) for Serialization Execution System (SES) solutions in our Packaging lines, you will...and equipment + 2+ years experience in GMPs and computer systems validation ( CSV… more
    Lilly (07/11/25)
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  • Principal Analytical Technical Steward-API EM

    Lilly (Indianapolis, IN)
    …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... data including data released from CM (Contract Manufacturers), stability, process validation , and reference standard characterization. + Utilizes technical skills to… more
    Lilly (07/10/25)
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  • Engineer - MES System

    Lilly (Indianapolis, IN)
    …for this employment position._ **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP ... the latest 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 (06/14/25)
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  • Engineer - Automation/Process - Serialization

    Lilly (Indianapolis, IN)
    …to packaging processes and equipment + 1+ years of experience in GMPs and computer systems validation ( CSV ) **Additional Skills/Preferences:** + ... with the different OEMs + Technically understand the integration of the serialization system with the OEM, ensuring the OEM equipment is designed, programmed and… more
    Lilly (06/12/25)
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  • Senior Manager, IT - GxP Computer…

    Bristol Myers Squibb (Indianapolis, IN)
    …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
    Bristol Myers Squibb (07/13/25)
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  • Senior Validation Engineer, QRM

    Cornerstone onDemand (Indianapolis, IN)
    …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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  • Validation Engineer

    PACIV (Indianapolis, IN)
    PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and ... Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis). Job Description: The Validation … more
    PACIV (06/13/25)
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  • Senior Engineer, Facilities & Maintenance CLT

    Novo Nordisk (Bloomington, IN)
    …+ Draft, review, execute, and approve protocols and summary reports related to Automation System Validation ( CSV ).. + Review and approve changes to ... Engineering Skills: + Act as key Subject Matter Expert (SME) for automation design, systems integration and CSV (Automation Only) + Apply and enhance existing… more
    Novo Nordisk (06/30/25)
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