• Associate Engineer - Process - Utilities

    Novo Nordisk (Bloomington, IN)
    …audit observations and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for ... of validated utility supplies. These utilities encompass tap/purified water, wash/cleaning systems , clean steam, clean gases, HVAC systems , cooling agents,… more
    Novo Nordisk (04/09/25)
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  • Engineer - Process - Formulation

    Novo Nordisk (Bloomington, IN)
    …audit observations and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for ... equipment + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance… more
    Novo Nordisk (04/10/25)
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  • Representative, QA CLT

    Novo Nordisk (Bloomington, IN)
    …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality ... systems requirements. This includes systems implementation and...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of… more
    Novo Nordisk (04/12/25)
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  • Analyst, QA CLT

    Novo Nordisk (Bloomington, IN)
    …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality ... systems requirements. This includes systems implementation and...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of… more
    Novo Nordisk (02/22/25)
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  • Senior Engineer

    Lilly (Indianapolis, IN)
    …delivery of key site strategic initiatives. + Compliance Knowledge: Possess knowledge of computer system validation and related practices, including GMP, 21 ... implementation, following quality procedures (ie, Change Control), create and execute validation requirements, and support manufacturing systems . The role will… more
    Lilly (03/04/25)
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  • Sr./Principal Engineer - Lab Automation…

    Lilly (Indianapolis, IN)
    …equipment platforms. + Develop data/process workflows, verification testing plans and computer system validation documentation packages. + Navigate ... standards and agencies such as: ISO, GAMP5, cGMP and FDA + Collaborate with all stakeholders to ensure consistent...8+ years of industry experience working with analytical equipment computer system validation and remediation… more
    Lilly (03/27/25)
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  • Clinical Study Build Programmer

    Lilly (Indianapolis, IN)
    …or more years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or ... 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 (04/25/25)
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  • Engineer, Quality

    Novo Nordisk (Bloomington, IN)
    …controls, capability analysis, material control, acceptance sampling and measurement systems . Duties include providing technical support for evaluation of ... Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual product review reports + Support tech transfers of new… more
    Novo Nordisk (03/04/25)
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  • Team Lead, EDC Programmer

    Cook Medical (West Lafayette, IN)
    …development, testing, and maintenance of Electronic Data Capture (EDC) systems to support clinical trials. This role ensures high-quality, regulatory-compliant ... clinical data collection systems and contributes to the overall success of clinical...edit checks, CRF standard libraries, EDC modules, and standard system reports. + Lead team reviews and User Acceptance… more
    Cook Medical (04/01/25)
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  • Principal Representative, QA-Microbiology

    Novo Nordisk (Bloomington, IN)
    …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality ... systems requirements. This includes systems implementation and...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of… more
    Novo Nordisk (04/26/25)
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