• Associate, Computer Systems Quality…

    Lilly (Indianapolis, IN)
    …with local business partners to influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation ( CSV ) of new and existing ... systems used within the Foundry are compliant with current computer systems validation expectations. This will include coordinating with the Foundry QA… more
    Lilly (08/27/25)
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  • Senior Principal Engineer - Automation Engineering…

    Lilly (Lebanon, IN)
    … Validation Plan. * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: + ... will provide CSV support leading and executing CSV activities for process automation systems across...and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum… more
    Lilly (09/27/25)
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  • Associate Director - Automation Engineering…

    Lilly (Lebanon, IN)
    …and visualization * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: ... * Staffing, including recruiting, resource planning, and succession planning. * Process validation and CSV work coordination. * Review and monitor financial… more
    Lilly (08/29/25)
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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 (10/01/25)
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  • Validation Specialist

    PACIV (Indianapolis, IN)
    …of all departmental computer systems . + Create, revise, and manage Computer Validation System ( CSV ) documentation to support validation execution ... is responsible for executing and managing periodic reviews of computer systems , and driving resulting action items...for any deficiencies resulting from periodic reviews. + Update Computer System Validation ( CSV ) documentation… more
    PACIV (09/27/25)
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  • IT Professional - Quality Engineer…

    Roche (Indianapolis, IN)
    …will review or ensure the creation of deliverables from Test Managers and Validation Leads for GxP-relevant systems , upholding an oversight role while ... do. In this you require strong expertise in IT validation within the healthcare domain and solid software testing...including performing maturity assessments. + You will ensure validated systems remain audit-ready by managing IT controls such as… more
    Roche (09/18/25)
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  • Senior Validation Engineer - Project Lead

    PACIV (Indianapolis, IN)
    …protocols, and final reports. + Proficient in Commissioning & Qualification (C&Q) and/or Computer System Validation ( CSV ), with a solid understanding of ... and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments. We are seeking a Senior… more
    PACIV (09/28/25)
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  • IT Software Engineer Quadient

    Alight (IN)
    …& AWS + Linux Server Commands and Management + Data Formats: JSON, XML, CSV + Mainframe systems , commands and utilities + JCL **Years of Experience:** ... candidate will work across multiple platforms-including Quadient, and mainframe systems -to support, customize, and improve client-facing print and electronic… more
    Alight (08/20/25)
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  • MES System Engineer - Syncade or PharmaSuite

    Lilly (Lebanon, IN)
    …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 ... will apply the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact to our environment.… more
    Lilly (08/14/25)
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  • Application Support Lead

    Lilly (Lebanon, IN)
    …team in executing with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. ... latest high-tech equipment, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact... (Windows, etc.), and Cisco Infrastructure. Basic understanding of CSV ( Computer system Validation ) &… more
    Lilly (09/16/25)
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