- Actalent (Clayton, NC)
- …or more core validation areas (sterilization, cleaning, process or computer validation ) preferred. Experience in cGMP documentation practices & regulations ... Our client, an expanding biopharmaceutical company, is seeking a Validation Specialist to join their team. They will primarily be responsible for performing… more
- Novo Nordisk (Durham, NC)
- …one or more core validation areas (equipment, cleaning, process, or computer validation ) preferred + Experience in cGMP documentation practices & regulations ... Position Coordinate & drive implementation of science & risk-based validation . The incumbent will provide input to project team...required + Basic computer skills including experience in the use of Microsoft… more
- Lilly (Concord, NC)
- …role will function as a Computer System Quality Assurance (CSQA) / Computer System Validation (CSV) Subject Matter Expert, working with Global Facility ... of test cases, test execution, discrepancy resolution, etc. and assure that validation artifacts follow Good Documentation Practices.** **Assure computer systems… more
- J&J Family of Companies (Wilson, NC)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data ... Medicine is responsible for developing a process for and performing of validation of computer and/or automation systems compliance current Good Manufacturing… more
- CREO (Durham, NC)
- …projects, from initial assessment and requirements gathering to implementation, validation , and post-implementation support. This includes Computer Systems ... Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA). + Lead technical discussions, document...GAMP 5 + SDLC and custom software development + Computer Systems Validation (CSV), Computer … more
- Novo Nordisk (Durham, NC)
- …core validation areas (packaging, API, cleaning, utilities, process, or computer validation ) required + Knowledge of statistical methods (hypothesis testing, ... Project Management, Validation , etc.) required + Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity… 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, ... the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance Manufacturing… 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
- Lilly (Durham, NC)
- …least 1 year of relevant work experience in information technology, engineering, computer system validation , quality control support or related areas ... systems (ie Veeva QualityDocs, Tulip, etc.) + Solid knowledge of Computer System Validation process + Demonstrated ability to analyze, anticipate, and resolve… more
- Lilly (Concord, NC)
- …manufacturing required + Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation ... understanding of the process and its associated equipment, facilities, computer systems and operations + Lead and establish annual...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… more
Recent Searches
- electrical manufacturing technician ii (United States)
- hybrid marketing analyst coordinator (United States)
Recent Jobs
-
Senior Manager, SAP Basis Security Governance
- Procter & Gamble (Cincinnati, OH)