• Principal Engineer, Validation

    Novo Nordisk (Bloomington, IN)
    …Nordisk and help us make what matters. Position Responsible to lead validation strategy and mentor engineers/senior engineers on execution. Relationships Reports to ... Manager, Validation . Essential Functions + Equipment Validation +...and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry… more
    Novo Nordisk (05/14/25)
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  • Sr. Quality Engineer, Validation

    Cardinal Health (Indianapolis, IN)
    …waste and inventory reductions. **_Responsibilities_** + Conducts & develops validation and qualification protocols, projects and studies supporting manufacturing ... facility start-up and operation. Validation documentation to ensure products are manufactured in accordance...Consultant working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device). + Experience… more
    Cardinal Health (07/24/25)
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  • Engineer, Engineering - Process (Days)

    Novo Nordisk (Bloomington, IN)
    …selection and integration of automated manufacturing equipment. + Partner with commissioning and validation teams to meet FDA GMP compliance. + Draft, revise, ... will work closely with process engineering, operations, manufacturing science & technology, validation , and IT teams to ensure our automation systems are robust,… more
    Novo Nordisk (07/31/25)
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  • Associate Director, MSAT, Downstream Drug…

    Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
    …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities… more
    Otsuka America Pharmaceutical Inc. (07/18/25)
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  • Advisor - Electronic Lab Systems (LabVantage LIMS…

    Lilly (Indianapolis, IN)
    …This role will provide quality assurance expertise in the implementation, validation , ongoing maintenance, and lifecycle management of electronic laboratory and ... are designed, deployed, and managed in full compliance with global regulatory standards ( FDA , EMA, ICH), industry guidelines (GAMP 5, 21CFR Part 11, EU Annex 11),… more
    Lilly (07/09/25)
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  • Additive Manufacturing Engineer II

    Ricoh Americas Corporation (Indianapolis, IN)
    …models and CAD drawings, process translation and development, equipment validation , and material resourcing and characterization. The Additive Manufacturing Engineer ... instructions for incoming contract manufacturing. Ensure compliance with ASTM, ISO 13485, FDA , and other standards for medical device manufacturing. Act as Subject… more
    Ricoh Americas Corporation (07/31/25)
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  • Sr. Manager, Quality Assurance for Quality Control

    Bristol Myers Squibb (Indianapolis, IN)
    …operations such as sample management, testing, and data review, method development, validation , and transfer, equipment validation , and associated projects. The ... of QC investigations, change control records, Standard Operating Procedures, Method validation and transfer documents, and technical protocols, and assists in… more
    Bristol Myers Squibb (07/29/25)
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  • Process Engineer - Formulation

    Novo Nordisk (Bloomington, IN)
    …equipment + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance ... with FDA GMP requirements + Draft SOPs for building operation,...sub-networks, software, etc.) + Apply and enhance existing automation validation programs for the validation of new… more
    Novo Nordisk (07/30/25)
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  • Automation Engineer - Process

    Novo Nordisk (Bloomington, IN)
    …Functions + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance ... with FDA GMP requirements + Draft SOPs for building and...future capital projects + Apply and enhance existing automation validation programs for the validation of new… more
    Novo Nordisk (07/05/25)
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  • Senior Engineer, Facilities & Maintenance CLT

    Novo Nordisk (Bloomington, IN)
    …team + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities + Manage ... integration and CSV (Automation Only) + Apply and enhance existing automation validation methods and templates for the qualification of new and existing production… more
    Novo Nordisk (06/30/25)
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