- Cardinal Health (Raleigh, NC)
- …+ Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation ( CSV ) methodologies. + Define technical ... You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team… more
- Fujifilm (Holly Springs, NC)
- …https://www.fujifilm.com/us/en/about/region/careers **Job Description** **What You'll Do** + Ensures that Computer System Validation is performed to a ... **Position Overview** The Automation Engineer 2, CSV will provide support to the Drug Substance...the change control process + Helps to maintain the validation status of DSM Automation Computerized Systems … more
- Mentor Technical Group (NC)
- …for the development and execution of Computer System Validation ( CSV ) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as the ... is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in configuring… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …adherence + IT Infrastructure Management, Server/Network Management and support, Validation /Qualification of Equipment's ( CSV ) + Install Infrastructure at ... and escalate, if issues from corporate team for corporate systems + Support for the Track and Trace system...IT helpdesk operations /Technical Support + Management and support, Validation /Qualification of Equipment's ( CSV ) + Management &… more
- J&J Family of Companies (Wilson, NC)
- …contact AskGS to be directed to your accommodation resource. **Required Skills:** Computer System Validation ( CSV ) **Preferred Skills:** Artificial ... Kroeber PAS-X MES, including MBR design, vendor management, production, validation and development systems , system standards, and...from clients. + Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP… more
- Lilly (Concord, NC)
- …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 ... will apply the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact to our environment.… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- … systems , hardware, network security, storage, software, and other computer -related systems . Collaborate with relevant teams to create corrective ... operations and technical support. + Capable of managing and supporting equipment validation /qualification ( CSV ). Leadership / Managerial Attributes + Ability to… more
- Cardinal Health (Raleigh, NC)
- …Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/ CSV ( Computer System Validation ), DSCSA(Drug Supply Chain ... products company. We provide customized solutions for hospitals, healthcare systems , pharmacies, ambulatory surgery centers, clinical laboratories, physician offices… more
- Cambrex High Point (High Point, NC)
- …+ Knowledge and Experience in Computer System Validation ( CSV ). + Knowledge of Electronic Quality Management/Document Systems preferred. + Excellent ... and/or lead project and site risk assessments relative to quality management systems and impact to client projects/regulatory filings. + Obtain, maintain, and manage… more