• 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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 (06/03/25)
    - Related Jobs

  • Engineer, Quality ( M-F Day Shift )

    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 (06/03/25)
    - Related Jobs

  • 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)
    - Related Jobs

  • Manager, QA ( PM or Weekend Shift )

    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 (06/03/25)
    - Related Jobs

  • 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)
    - Related Jobs

  • Senior Engineer, Quality

    Novo Nordisk (Bloomington, IN)
    …Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual product review reports + Support tech transfers of new ... products + Support and review process and engineering validation work + Investigate QC microbiology deviations and change...manufacturing groups + Knowledgeable in technical guidance documents from FDA , EMA, PDA, ISPE, ICH, ISO, PIC/S and other… more
    Novo Nordisk (06/19/25)
    - Related Jobs

  • Senior Engineer, Engineering - Process

    Novo Nordisk (Bloomington, IN)
    …+ Technical Requirements : + Ability to use Excel, Word, and other office systems + Strong understanding of cGMP regulations, FDA guidelines, and industry ... Leadership and Strategy: + Lead the design, development, and validation of aseptic manufacturing processes, ensuring adherence to the...as a Subject Matter Expert (SME) across multiple validated systems and at least one specific technical field. +… more
    Novo Nordisk (05/17/25)
    - Related Jobs

  • Lead Consultant - MES OpCenter - Remote

    Cognizant (Indianapolis, IN)
    …management and delivery with benefits delivered as committed required. + Experience in GxP systems , Computer System Validation , and consistent track ... responsible for: + Act as subject matter expert on system design and architecture. + Solutioning and designing new...record in the support of FDA regulated systems and business required. +… more
    Cognizant (06/04/25)
    - Related Jobs