• Principal Engineer, Validation

    Novo Nordisk (Bloomington, IN)
    … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... other validation technical disciplines, such as equipment validation , computer system validation...plans, protocols, and reports related to commissioning, qualification, and validation of simple systems and processes. This… more
    Novo Nordisk (05/14/25)
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  • Principal Validation Engineer

    Cardinal Health (Indianapolis, IN)
    …systems including manufacturing equipment, laboratory instrumentation, utilities, spreadsheets, and computer systems . + Develop and/or review master level ... guidance to local project teams on a range of validation and qualification initiatives to ensure existing systems...or a Physical Science. + 5+ years of relevant validation experience preferred. + Knowledgeable in FDA … more
    Cardinal Health (06/13/25)
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  • Validation CQV Engineer

    Insight Global (Indianapolis, IN)
    …will have experience managing an environment with human safeties involved. It could be a computer system validation process or a validation equipment ... will go through a series of CQV (Commission, Qualification, Validation ) within an FDA regulated environment for...to go onsite in Castleton area -Familiarity of HVAC systems null We are a company committed to creating… more
    Insight Global (06/20/25)
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  • Engineer, Engineering - Process

    Novo Nordisk (Bloomington, IN)
    …Draft, review, execute, and approve protocols and reports related to Computerized System Validation (CSV), including the management of deviations during ... team to establish operational protocols that ensure compliance with FDA GMP requirements. + Draft, review, and update SOPs...as the primary Subject Matter Expert (SME) for Computerized System Validation . + Review and approve changes… more
    Novo Nordisk (05/17/25)
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  • Engineer, Facilities & Maintenance

    Novo Nordisk (Bloomington, IN)
    …+ Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution + ... audit observations and corrective actions as it pertains to building automation system validation + Identify and implement improvement opportunities for… more
    Novo Nordisk (06/26/25)
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  • Automation Engineer - Process

    Novo Nordisk (Bloomington, IN)
    …+ Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution + ... audit observations and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for… more
    Novo Nordisk (04/05/25)
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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 computerized ... + Technical Requirements: + Ability to use Excel, Word, and other office systems + Strong understanding of cGMP regulations, FDA guidelines, and industry… more
    Novo Nordisk (04/01/25)
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  • Principal Architect - MES

    Lilly (Indianapolis, IN)
    …maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) ... the latest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...direction and standards. + Experience leading or supporting the Computer System Validation of IT… more
    Lilly (05/21/25)
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  • Associate Director - Solutions Architect - Global…

    Lilly (Indianapolis, IN)
    …meet quality and compliance standards. Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations will be vital in ... environment and manage multiple tasks simultaneously. + Experience with Computer System Validation . + Familiarity...+ Familiarity with industry standards such as GS1 and FDA DSCSA regulations + System integration with… more
    Lilly (06/18/25)
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  • Senior Manager, Quality Control (Chemistry) Days

    Novo Nordisk (Bloomington, IN)
    …through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and ... for routine testing + Supports instrument onboarding and maintenance + Method Validation + Accountable for daily operations to maintain Quality standards and project… more
    Novo Nordisk (04/26/25)
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