- Actalent (Greenville, NC)
- …to be available for urgent off-hours inquiries. Responsibilities + Govern validation activities for equipment, processes, computer software, and cleaning ... Job Title: Quality Assurance Validation Engineer Job Description We are seeking an...Job Description We are seeking an experienced and meticulous Validation Engineer III. The ideal candidate will have a… more
- Fujifilm (Holly Springs, NC)
- …https://www.fujifilm.com/us/en/about/region/careers **Job Description** **What You'll Do** + Ensures that Computer System Validation is performed to a ... the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance Manufacturing… more
- Parexel (Raleigh, NC)
- …acquisition and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications ... with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded… more
- Lilly (Concord, NC)
- …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation (CSV) principles (eg, GAMP 5, 21 CFR ... and site teams, MES System Engineer will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges.… 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
- Mentor Technical Group (NC)
- …our Talent Bank. + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory ... is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in configuring… more
- ThermoFisher Scientific (Greenville, NC)
- …and reports. + Validation related deviations and discrepancies. + Process Validation (PV), Cleaning Validation , and Computer System related protocols ... Description** The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory… more
- Cardinal Health (Raleigh, NC)
- …will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team develops ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical requirements… more
- J&J Family of Companies (Wilson, NC)
- …AskGS to be directed to your accommodation resource. **Required Skills:** Computer System Validation (CSV) **Preferred Skills:** Artificial Intelligence (AI), ... of site's Kroeber PAS-X MES, including MBR design, vendor management, production, validation and development systems, system standards, and interfaces to DCS & IT… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and Experience requirements by level:** **Sr. Automation Engineer I - Validation ** Master's Degree - Engineering, Automation, Computer , Industrial, ... Related and 3 years of direct experience in automation engineering and/or validation **or** Bachelor's Degree - Engineering, Automation, Computer , Industrial,… more