• Sterility Assurance Specialist

    Cook Medical (Bloomington, IN)
    …multiple projects/tasks related to ensuring continued compliance with sterilization validation and product adoption requirements. The Sterility Assurance Specialist ... * Collaborate and approve product/process changes to ensure sterilization validation remains compliant. Request testing as needed* Develops knowledge in… more
    Cook Medical (07/30/25)
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  • Advisor - LEM

    Lilly (Indianapolis, IN)
    …+ Provide technical oversight of third-party organizations throughout the transfer, validation and implementation of immunogenicity and biomarker assays used in ... PhD degree in a scientific area (eg, immunology, biochemistry, pharmaceutical sciences) with 0-3 years of post-graduate experience. **Additional Preferences**… more
    Lilly (07/30/25)
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  • Clinical Study Build Programmer

    Lilly (Indianapolis, IN)
    …years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical , biotech, CRO or regulatory ... and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. **This is a hybrid… more
    Lilly (07/30/25)
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  • Associate - QA Rep for Dry Product External…

    Lilly (Indianapolis, IN)
    …support for Quality Control activities + Experience on equipment qualification, system validation and process validation . + Thorough technical understanding of ... quality systems and regulatory requirements. + Knowledge of pharmaceutical manufacturing operations. + Demonstrated coaching and mentoring skills. + Experience in… more
    Lilly (07/24/25)
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  • Scientist I, Microbiology

    Bristol Myers Squibb (Indianapolis, IN)
    …in Indianapolis. This role will conduct method development and method validation along with day-to-day activities to support commercialization of aseptically ... Support and perform testing for microbial test method development, qualification and validation for bioburden, sterility, and endotoxin testing + Support review and… more
    Bristol Myers Squibb (07/24/25)
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  • Sr. Principal Manufacturing Scientist - Lebanon…

    Lilly (Lebanon, IN)
    …technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs ... process variability and capability. + Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the… more
    Lilly (07/23/25)
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  • Associate Director-TS/MS Sterility Assurance…

    Lilly (Indianapolis, IN)
    …and support technical activities related to aseptic processing, including validation , deviation investigations, and process improvements. + Ensure compliance with ... internal audit activities. + Review and approve technical documentation, including validation protocols, reports, and quality records. + Drive continuous improvement… more
    Lilly (07/23/25)
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  • Sr. Manager - Global Engineering Services

    Lilly (Indianapolis, IN)
    …+ Proven leadership of global teams, vendor management, and system validation . + Expertise in maintenance/reliability systems (GMARS/Maximo, SAP PM) and document ... CAD, and drawing management. **Preferred:** + Experience in the pharmaceutical , biotech, or manufacturing industries. **Key Competencies:** + Strategic Planning… more
    Lilly (07/19/25)
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  • Automation Engineer - CMO Support Device…

    Lilly (Indianapolis, IN)
    …and implement actions. + Maintain process validations including computer system validation . In addition to creation, execution, and coordination of validation ... / Accountability + Experience with Engineering in a Regulated Pharmaceutical Environment + cGMPs/Commissioning and Qualification Experience with Rockwell Suite… more
    Lilly (07/15/25)
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  • Senior Specialist, Quality Control Chemist II

    Cardinal Health (Indianapolis, IN)
    …materials, in-process, and product samples. + Executes method verification, validation , and/or transfer protocols, analytical equipment qualification protocols, or ... computer system validation test scripts, as needed. + Performs stability testing...21 CFR 210, 211 in the FDA regulated industry ( Pharmaceutical or Medical Device) preferred. + Has experience in… more
    Cardinal Health (06/26/25)
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