- GE Vernova (Wilmington, NC)
- **Job Description Summary** Work on I&C Systems team with a focus on work planning, technical approach, design assurance, and execution excellence from ITO thru OTR ... throughout design release to manufacturing or supplier including production, validation , installation, and commission tests. + Champion conformance with regulations… more
- Reynolds American (Winston Salem, NC)
- …+ Regulatory Experience: Experience with FDA-relevant systems and/or processes and computer system validation . **WE ARE REYNOLDS AMERICAN-A member of the ... AND KNOWLEDGE** + Shown experience of 3 years with manufacturing systems processes, systems architecture, and systems support or highly shown experience.… more
- Novo Nordisk (Durham, NC)
- …core validation areas (packaging, API, cleaning, utilities, process, or computer validation ) required + Knowledge of statistical methods (hypothesis testing, ... product release + Quality oversight, review & approval of validation activities associated with projects, new systems ,...Validation , etc.) required + Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5,… more
- ThermoFisher Scientific (Greenville, NC)
- …Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data ... safety, and delivering COVID-19 solutions. **Location/Division Specific Information** The Computer System Quality Assurance Team provides quality oversight of… more
- ManpowerGroup (Raleigh, NC)
- …reports. **What's Needed?** + Bachelor's degree in a technical field such as computer technology, computer systems technology, information systems , ... a regulated environment. + Greenfield project experience. + Familiarity with electronic validation systems (eg, KNEAT Gx). **What's in it for me?** + Opportunity… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **Job Description** **What You'll Do** + Ensures that Computer System Validation is performed to a consistently high standard, ... summary reports) + Helps to assess the impact of Computer System modifications through the change control process +...the change control process + Helps to maintain the validation status of DSM Automation Computerized Systems … more
- VTI Life Sciences (Raleigh, NC)
- …(preferred but not required). They must have previous Engineering and/or Validation experience. The candidate will have some business development responsibilities ... with periods as high as 20% Preferred qualifications: BS degree in computer science, engineering, analytics, biology, or another technical field strongly preferred.… more
- Volvo Group (Greensboro, NC)
- …system/component designs, vehicle integration, and ensuring Verification and Validation plans fulfil Feature development objectives. Additional Responsibilities: + ... PDP (Product Delivery Plan) with requirements and correlation to verification & validation methods. + Collaborate with Vehicle Engineering & complete vehicle test… more
- Lilly (Concord, NC)
- …of laboratory IT systems , population of master data, and configuration of systems ). + Proficiency with computer systems including Microsoft Office ... expert. **Key Objectives/Deliverables:** + Performs and/or supports the laboratory with the validation of laboratory equipment and software systems . + Supports… more
- Lilly (Concord, NC)
- …status reporting and manage issue escalations . Produce and maintain local project and validation documentation . Ensure systems remain in a validated state and ... . Demonstrated ability to influence without authority . Solid knowledge of Computer System Validation process . Demonstrated ability to analyze, anticipate,… more