- ThermoFisher Scientific (Greenville, NC)
- …Validation related deviations and discrepancies. + Process Validation (PV), Cleaning Validation , and Computer System related protocols and reports. + ... Description** The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory… more
- Amgen (Holly Springs, NC)
- …for SDLC methodologies and 21 CFR Part 11. + General experience with computer validation and change control methodology. + Experience with computerized ... us and transform the lives of patients while transforming your career. **Manufacturing Systems Engineer** **What you will do** Let's do this. Let's change the world.… more
- General Motors (Raleigh, NC)
- **Job Description** **Role:** As a Staff Software Systems Engineer on the Behavior Validation team within the AV organization, you will play a critical role in ... experience in system engineering and requirements management including system analysis, requirements authoring, test generation, and validation activities… more
- Amazon (Raleigh, NC)
- … Computer Engineering - 5+ years experience of hardware design and validation of components, subsystems and systems - Experience performing PCB schematic ... AWS sites and Asia. Key job responsibilities * Develop and implement detailed validation plans tailored to specific hardware designs * Collaborate with design 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
- Reynolds American (Winston Salem, NC)
- …supporting Product, R&D, and regulatory business teams, with understanding of FDA Computer System Validation requirements and validated applications. + ... 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
- Teleflex (Morrisville, NC)
- …controls for Application, ensuring adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a ... and service providers * Own the process to deploy system changes through sandbox, development, QA and production environments....* Bachelor's degree in a technical field such as Computer Science or Information Systems (a combination… more
- General Motors (Raleigh, NC)
- **Job Description** **Role Overview:** As a Technical Lead within the Validation , Tools, Acceleration (VTA) team under the Simulation, Evaluation, and Data ... strategy to ensure alignment with broader company objectives, designing and implementing systems to support AV / ADAS development. You will drive software… more
- Cambrex High Point (High Point, NC)
- …or Corporate/Client Audits when necessary Qualifications/Skills + Knowledge and Experience in Computer System Validation (CSV). + Knowledge of Electronic ... 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
- Ford Motor Company (Raleigh, NC)
- …experienced Software Developer in Test to join our team, specializing in embedded systems with a focus on automotive applications. As a Software Developer in Test, ... automated tests for our embedded software products. Your expertise in embedded systems and automotive industry knowledge will help ensure the quality and reliability… more
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