• 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 (06/26/25)
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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 ... met. + Develops cGMP operating procedures that relate to process, information systems , and equipment validation /qualification. + Ensures compliance with SOPs… more
    Biomat USA, Inc. (06/26/25)
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  • Validation Area Specialist - FFEx…

    Novo Nordisk (Clayton, NC)
    …obtainment. Serves as a source of expertise in the group for validating new systems + Ensure compliance of validation protocols executed are aligned with local, ... us make what matters. The Position Primary responsibility is to provide/lead validation services required for the successful delivery of highly automated warehouse… more
    Novo Nordisk (06/05/25)
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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...responsible for the implementation, execution and assessment of quality systems , procedures, and records to support compliant GMP operations.… more
    Astellas Pharma (06/06/25)
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  • MES Systems Engineer

    Lilly (Durham, NC)
    …maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) ... ground up as a member of the site IT organization. The Manufacturing Execution Systems (MES) Systems Engineer is responsible for the deployment and continuous… more
    Lilly (05/21/25)
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  • CSV Specialist

    Mentor Technical Group (NC)
    …for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as ... 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. +… more
    Mentor Technical Group (06/18/25)
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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 (06/08/25)
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  • Process Engineer 2 - Engineering Assurance

    GRAIL (Durham, NC)
    …maintaining accurate equipment records in asset management and quality management systems , ensuring traceability and compliance with CLIA/CAP, FDA 21 ... 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… more
    GRAIL (06/26/25)
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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 (06/24/25)
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  • CAPA Engineer

    ConvaTec (Greensboro, NC)
    …* Supports site/s oversight of the Non-Conformance (NC) and Corrective Action/Preventive Action (CAPA) system . * Ensures compliance to FDA 21 CFR Part 820, ISO ... leadership in handling of nonconformances/CAPA's/etc. The role supports key quality system activities such as internal audits, process and product audits,… more
    ConvaTec (06/24/25)
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