- Parexel (Raleigh, NC)
- …and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications -** ... or other specialized computerized systems ** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of… more
- Lilly (Concord, NC)
- …experience with C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control ... understanding of the process and its associated equipment, facilities, computer systems and operations + Lead and...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… 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)
- …, internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** Computer System Validation (CSV) **Preferred Skills:** ... site's Kroeber PAS-X MES, including MBR design, vendor management, production, validation and development systems , system standards, and interfaces to DCS &… 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 ... team. Join us and transform the lives of patients while transforming your career. System Administrator - Senior Associate **What you will do** Let's do this. Let's… more
- 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
- 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
- Insight Global (Clayton, NC)
- … systems management within a cGMP pharmaceutical environment. -Proven expertise in computer system validation (CSV), data integrity, and compliance ... Job Description Insight Global is seeking an IT Systems Manager for a pharmaceutical client in the Raleigh area. The IT Systems Manager will lead and manage… more
- Genentech (Holly Springs, NC)
- …monitoring, capacity planning, design, installation, configuration, and upgrade of platform. + Execute computer system validation and control system ... System Platforms including Syncade MES, DeltaV Distributed Control System , PLC's, Lab Data Systems (Smartline Data...systems . + Qualification experience related to control and computer systems . + Ability to generate engineering… more
- Lilly (Concord, NC)
- …and execute validation activities for our Global TSMS (Technical Systems Management System ) initiatives. Responsibilities Validation Leadership: Lead ... and effective project completion. Risk Management: Develop and implement risk-based validation approaches, identifying potential risks to system functionality,… more