- J&J Family of Companies (Wilson, NC)
- … Computer system Validation in a cGMP pharmaceutical facility working with FDA regulations + Experience in Computer system Validation working with ... of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data… more
- CREO (Durham, NC)
- … Validation (CSV), Computer Software Assurance (CSA) and modern validation methodologies + Familiarity with FDA regulations, as applicable to automated ... projects, from initial assessment and requirements gathering to implementation, validation , and post-implementation support. This includes Computer Systems… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and/or validation OR + Bachelor's degree - Engineering, Automation, Computer , Industrial, Manufacturing, Related and 5 years of direct experience in automation ... and/or validation OR + Bachelor's degree - Engineering, Automation, Computer , Industrial, Manufacturing, Related and 6 years of direct experience in automation… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits. Maintains professional knowledge through familiarity with… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Provides leadership and mentoring across the analytical team ... safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits. Maintains professional knowledge through familiarity with… more
- Fujifilm (Holly Springs, NC)
- …go live for the site. This includes migration of static data, configuration, validation and working with colleagues to ensure successful setup of Labware LIMS v.8.* ... Writes test scripts for new LIMS functionality and participate in the validation of new functionality releases* Develops and maintains process configurations in… 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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …a drug product that is safe for human use. + Executes commissioning and validation activities associated with a new building. This job description is intended to ... Ability to work a 24/7 rotating shift schedule. + Comfortable with using different computer systems to perform data entry. + Willingness to work with and learn from… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... + Maintain a clean and safe work-space + Maintain laboratory notebook and/or computer files (ie LIMS) according to standard, accepted practices + Participate in… more
- Novo Nordisk (Clayton, NC)
- …Wash/Sterilization, Filling, & media preparations through documentation, start-up and validation activities for a new production facility. Relationships Reports to ... & other documents + Assist in the start-up and validation of new equipment + Review standards to maintain...+ Minimum two (2) years of experience in an FDA regulated environment required + Aseptic processing experience required… more
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