- BioAgilytix (Durham, NC)
- …visibility into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA , EMA, or ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- 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
- 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 ... of our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and… more
- Astellas Pharma (Sanford, NC)
- …activities including but not limited to equipment, instruments, utilities, clean rooms, computer systems , and manufacturing process. + Evaluate and approve ... **Specialist, QA Validation (Onsite in Sanford, NC)** Do you want...oversight periodic review and lifecycle management activities for validated systems and computerized systems .Support revalidation as required… more
- United Therapeutics (Research Triangle Park, NC)
- …approve cGxP related documents (ie, product/ design specifications, computerized systems , validation protocols and reports (IOQ/PQ), analytical/microbiological ... manage and prioritize workloads, stressful situations, and deadlines + Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971,… more
- Fujifilm (Holly Springs, NC)
- …Engineer 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 on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation,...Science, or related fields, with 3 years of direct Computer System Validation experience in… more
- GRAIL (Durham, NC)
- …Assist the Quality Systems Software Business Owner/SME with validation and configuration maintenance/improvements, including testing for system ... 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 (Durham, NC)
- …control software). + Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with **QMS and FDA ... performance and uptime. + Partner with R&D, Software, and Quality teams on system changes, new equipment validation , and controlled rollouts. + Ensure vendor… more
- 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
- United Therapeutics (Research Triangle Park, NC)
- …testing activities for remediation activities, new project/product support (development, validation , etc.), implementation/maintenance of laboratory systems such ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
