• Director DBS - R&D & Leaf

    Reynolds American (Winston Salem, NC)
    …Experience supporting Product, R&D, and regulatory business teams, with understanding of FDA Computer System Validation requirements and validated ... and resourcing requirements. **What are we looking for?** + Bachelor's degree in Computer Science, IT, Software Engineering, or related field; Master's degree in … more
    Reynolds American (09/24/25)
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  • Specialist, QA Validation

    Astellas Pharma (Sanford, NC)
    **Specialist, QA Validation (Onsite in Sanford, NC)** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, ... This is an **Onsite** role in **Sanford, NC** . The **Specialist, QA Validation ** is responsible for providing quality assurance oversight and support for the… more
    Astellas Pharma (09/24/25)
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  • Validation Specialist

    Biomat USA, Inc. (Research Triangle Park, NC)
    …+ Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation . + Assures compliance with SOPs upon ... our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and… more
    Biomat USA, Inc. (08/08/25)
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  • Associate Director, QA Engineering - Combo…

    United Therapeutics (Research Triangle Park, NC)
    …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also… more
    United Therapeutics (09/26/25)
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  • Sr. IT Engineer 1, CSV

    Fujifilm (Holly Springs, NC)
    …1, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action items ... CSV experience in a cGMP pharmaceutical facility working with FDA regulations + Experience in Drug Substance Manufacturing (DSM),...Science, or related fields, with 3 years of direct Computer System Validation experience in a cGMP… more
    Fujifilm (08/11/25)
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  • MSAT Engineer-Thermal

    J&J Family of Companies (Wilson, NC)
    …Wilson, North Carolina. We are responsible for Process, Thermal & Cleaning Validation , Standardization of Equipment for New Product Introduction, and Life Cycle ... for an MSAT Engineer- Thermal to join our MSAT Validation team ; located in Wilson, NC! **Position Summary:**...knowledge and application of industry regulations including those of FDA , HPRA, EMEA and other authorities. + Excellent verbal… more
    J&J Family of Companies (09/30/25)
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  • Supervisor, Engineering Operations (2nd Shift…

    GRAIL (Durham, NC)
    …control software). + Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with **QMS and FDA ... 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 (08/22/25)
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  • Manager, QC Chemistry - Combo Products

    United Therapeutics (Research Triangle Park, NC)
    …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... with other departments to support equipment such as calibration or validation activities, inventorying materials, and coordinating disposals, as needed + Prepare,… more
    United Therapeutics (09/24/25)
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  • Manager, QC Microbiology - Combo Products

    United Therapeutics (Research Triangle Park, NC)
    …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... third party contract laboratories as applicable + Plan and execute method validation protocols for API, intermediates, drug substance, and drug product release and… more
    United Therapeutics (09/24/25)
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  • QA Manager, Analytical Services - Combo Products

    United Therapeutics (Morrisville, NC)
    …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... best practices + Review and approve laboratory instrumentation qualification and validation protocols, test method transfer protocols, and other testing protocols,… more
    United Therapeutics (09/24/25)
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