• Experienced Automation Engineer (CSV)

    J&J Family of Companies (Wilson, NC)
    …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... Coordinates and executes training of required personnel on the computer and automation systems validation ...working with FDA regulations + Experience in Computer system Validation working with… more
    J&J Family of Companies (04/27/25)
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  • IT Compliance and Quality Consultant

    CREO (Durham, NC)
    …gathering to implementation, validation , and post-implementation support. This includes Computer Systems Validation (CSV) and, importantly, applying ... GAMP 5 + SDLC and custom software development + Computer Systems Validation (CSV), ...(CSV), Computer Software Assurance (CSA) and modern validation methodologies + Familiarity with FDA regulations,… more
    CREO (04/25/25)
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  • Sr Systems Engineer / Principal…

    Lilly (Durham, NC)
    …maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) ... member of the site IT organization. The Manufacturing Execution Systems (MES) Principal Engineer is responsible for the deployment...a culture of compliance aligned with internal and external computer system quality standards. + Comply with… more
    Lilly (03/19/25)
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  • Sr Principal Systems Engineer: MES…

    Lilly (Durham, NC)
    …maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) ... member of the site IT organization. The Manufacturing Execution Systems (MES) Sr Principal Systems Engineer is...a culture of compliance aligned with internal and external computer system quality standards. + Comply with… more
    Lilly (03/19/25)
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  • Automation Engineer - DeltaV

    Grifols Shared Services North America, Inc (Clayton, NC)
    …scheduling, and commissioning. + Act as a technical expert, providing support for systems like DCS, PLC, SCADA, BAS, and validation processes. + Foster ... and/or validation OR + Bachelor's degree - Engineering, Automation, Computer , Industrial, Manufacturing, Related and 5 years of direct experience in automation… more
    Grifols Shared Services North America, Inc (04/05/25)
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  • Sr Quality Assurance Representative - Digital…

    ThermoFisher Scientific (Greenville, NC)
    …Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to ... Assurance oversight for PSG computerized systems for the entire system lifecycle from infrastructure qualification through application validation and… more
    ThermoFisher Scientific (04/26/25)
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  • Sr Specialist I, QC LIMS

    Fujifilm (Holly Springs, NC)
    …of the LIMS platform through the preparation and execution of test scripts for system validation * Liaises with end-users in the Laboratory to ensure changes to ... Sr. Specialist 1, QC LIMS supports the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific… more
    Fujifilm (03/15/25)
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  • Scientist II (ARD)

    Cambrex High Point (Durham, NC)
    …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits. Maintains professional knowledge through familiarity with… more
    Cambrex High Point (04/18/25)
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  • Principal Scientist II

    Cambrex High Point (Durham, NC)
    …data. Demonstrated understanding of method development and qualification / validation principles. Provides leadership and mentoring across the analytical team ... safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits. Maintains professional knowledge through familiarity with… more
    Cambrex High Point (03/20/25)
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  • Fractionation Technician - NFB (Days)

    Grifols Shared Services North America, Inc (Clayton, NC)
    …+ Ability to work a 24/7 rotating shift schedule. + Comfortable with using different computer systems to perform data entry. + Willingness to work with and learn ... company safety guidelines and programs + Demonstrate care of facility, equipment, systems , and product + Demonstrate appropriate personal hygiene and proper gowning… more
    Grifols Shared Services North America, Inc (04/17/25)
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