- AUROBINDO (Durham, NC)
- …improve compliance and throughputSupport deplloyment of the electronic laboratory notebook system through training, validation script review, and validation ... experience are required. Review experience within an electronic laboratory notebook system is preferred. Experience with management and qualification of electronic … more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Herbalife (Winston Salem, NC)
- …handling, processing, and packaging * Basic knowledge of cleaning validation and computer system validation . * Experience with Lean Manufacturing and ... Sr. Engineer, Validation Category: Quality Position Type: Regular Full-Time External...(including MS Project and Visio) * Understanding of mechanical systems as they relate to manufacturing equipment, facilities equipment… 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 ... NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of … 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
- Lilly (Concord, NC)
- …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation (CSV) principles (eg, GAMP 5, 21 ... the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
- Lenovo (Morrisville, NC)
- …**About Our Team** Lenovo's Cloud Service Provider Group (CSP) is seeking a ** System ** **Engineer** with server or GPU test/ validation and debug expertise. At ... Server System Engineer **General Information** Req # WD00080624 Career...experience * Bachelor's or higher in Electrical Engineering or Computer Engineering * Test/ validation and debug experience… more
- Fujifilm (Holly Springs, NC)
- …+ Experience in a GMP manufacturing environment. + Understanding of change controls, computer systems validation based on GAMP5, 21CFR/Part 11 compliance ... **Position Overview** The IT Engineer 2 - Scientific Systems manages IT instruments like cell counters and microscopes, ensuring these systems remain validated… more
- Mentor Technical Group (NC)
- …for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as ... environment is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in… more
- 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 ... NC site. This role will be part of our computer system validation team for...technical field. Preferred fields include Information Management, Information Technology, Computer Engineering, Management Information Systems , Computer… more
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