• Experienced Automation Engineer (CSV)

    J&J Family of Companies (Wilson, NC)
    … Computer system Validation in a cGMP pharmaceutical facility working with FDA regulations + Experience in Computer system Validation working with ... of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data… more
    J&J Family of Companies (06/26/25)
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  • Specialist, QA Validation

    Astellas Pharma (Sanford, NC)
    …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required Qualifications**… more
    Astellas Pharma (06/06/25)
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  • Validation Manager

    Biomat USA, Inc. (Research Triangle Park, NC)
    …and regions. **Summary:** Ensures current Good Manufacturing Practices (cGMP), FDA /Grifols Quality Systems, and other applicable regulatory requirements are met ... throughout the evaluation, review and disposition of validation and quality assurance/control documentation. **Primary Responsibilities:** + Manage department… more
    Biomat USA, Inc. (06/26/25)
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  • Validation Area Specialist - FFEx…

    Novo Nordisk (Clayton, NC)
    …us make what matters. The Position Primary responsibility is to provide/lead validation services required for the successful delivery of highly automated warehouse ... Senior Project Manager, Site Capacity & Upfit. Essential Functions + Provide validation & technical support through the preparation, execution, data analysis, &… more
    Novo Nordisk (06/05/25)
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  • Engineer III, QA

    ThermoFisher Scientific (Greenville, NC)
    …off-hours questions.** **Key Responsibilities:** + Quality Validation : Govern validation activities for equipment, processes, computer software, and cleaning ... to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will have a strong...Associate's degree is minimally required; A Bachelor's degree in Computer Science, Engineering, or a related field, or an… more
    ThermoFisher Scientific (06/11/25)
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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 (06/08/25)
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  • Associate II, Upstream Manufacturing

    Astellas Pharma (Sanford, NC)
    …the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and ... yet is not limited to; equipment testing, SOP/batch record generation, and validation protocol execution support. Once commissioning and validation is complete,… more
    Astellas Pharma (06/21/25)
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  • Process Engineer 2 - Engineering Assurance

    GRAIL (Durham, NC)
    …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... executed in compliance with cGMP/GLP, QMS, and regulatory standards (eg, CLIA/CAP, FDA 21 CFR Part 820, ISO 13485). It involves creating and maintaining… more
    GRAIL (06/26/25)
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  • Fractionation Technician NFB (Days)

    Grifols Shared Services North America, Inc (Clayton, NC)
    …a drug product that is safe for human use. + Executes commissioning and validation activities associated with a new building. This job description is intended to ... 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 from… more
    Grifols Shared Services North America, Inc (06/24/25)
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  • CSV Specialist

    Mentor Technical Group (NC)
    …our Talent Bank. + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory ... comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science...+ Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have… more
    Mentor Technical Group (06/18/25)
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