• Engineer - Automation/Process - Serialization

    Lilly (Indianapolis, IN)
    …packaging processes and equipment + 1+ years of experience in GMPs and computer systems validation (CSV) **Additional Skills/Preferences:** + Experience in ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP,… more
    Lilly (06/12/25)
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  • Senior Specialist, Quality Control Chemist II

    Cardinal Health (Indianapolis, IN)
    … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. + Has experience in authoring… more
    Cardinal Health (06/26/25)
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  • Engineer - Serialization Lead, Packaging…

    Lilly (Indianapolis, IN)
    …related to packaging processes and equipment + 2+ years experience in GMPs and computer systems validation (CSV) + Experience in serialization and full ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP,… more
    Lilly (06/26/25)
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  • Clinical Study Build Programmer - eCOA

    Lilly (Indianapolis, IN)
    …key business partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. Portfolio Delivery + ... design specifications and enable successful implementation + Program and test data collection systems and associated data repository mappings for a trial or set of… more
    Lilly (04/30/25)
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  • Director, Compliance

    Sumitomo Pharma (Indianapolis, IN)
    …processes, and systems to enable accurate and timely data capture, validation , and reporting + Oversee and directly manage the collection, integration, and ... + Partner with internal and external partners/vendors to implement and/or enhance systems supporting transparency reporting + Serve as the subject matter expert on… more
    Sumitomo Pharma (06/07/25)
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  • Supervisor, QC (Weekends)

    Novo Nordisk (Bloomington, IN)
    …through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and ... verification + Accountable for completion of qPCR/PCR method development, qualification, validation , and execution + Accountable for daily operations of the site's… more
    Novo Nordisk (06/21/25)
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  • Engineer, Inspection/Packaging

    Novo Nordisk (Bloomington, IN)
    …and safety requirements + Ability to use Excel, Word, and other office systems + Understanding of cGMP regulations, FDA guidelines, and industry standards ... Inspection & Packaging working cross-functionally with support groups including Validation , Quality Assurance, Engineering, and Manufacturing Science & Technology +… more
    Novo Nordisk (05/02/25)
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