- Fujifilm (Holly Springs, NC)
- …+ Experience in a GMP manufacturing environment. + Understanding of change controls, computer systems validation based on GAMP5, 21CFR/Part 11 compliance ... **Position Overview** The IT Engineer 2 - Scientific Systems manages IT instruments like cell counters and microscopes, ensuring these systems remain validated… more
- BeOne Medicines (Pennington, NJ)
- …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). Previous experience in a ... experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems , or Master's Degree in Engineering, Computer Science or… more
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with… more
- Lilly (Pleasant Prairie, WI)
- …expertise to solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working with Global ... cross-functional teams and project management experience + Demonstrated proficiency with GMP computer systems validation including regulations governing them… more
- Endo International (Rochester, MI)
- …testing of qualified GMP equipment, facilities, utilities, computer systems and sterilization processes. + Ensure validation activities comply ... + Develop and execute protocols (IQ/OQ/PQ) for equipment, utilities, facilities and computer systems (eg, HVAC, water systems , autoclaves, environmental… more
- Lilly (Lebanon, IN)
- …within the applications to drive business process optimization. + Adhere to corporate computer systems validation policies and procedures. + Progress the ... which are interfaced with SAP. **Basic Requirements:** + Bachelor's degree in information systems , Computer Science, Supply Chain or related discipline + Minimum… more
- Bristol Myers Squibb (Devens, MA)
- … systems and manufacturing execution system recipes, computer systems , and laboratory instrumentation. + Implement validation philosophies and master ... regulatory inspection readiness. Work collaboratively with peers within the Validation Execution function, Manufacturing Systems , Information Technology,… more
- J&J Family of Companies (Titusville, NJ)
- …and Re-qualification, as well as PQ activities * In partnership with E&PS own Computer Systems Validation , including writing and driving CSV protocols, ... integrating cross-functional issues. **Preferred:** * Experience with equipment / systems commissioning/qualification/ validation , Process Automation, IT manufacturing … more
- Lilly (Pleasant Prairie, WI)
- …+ Previous experience with C&Q and Validation oversight including automation and computer systems validation + Demonstrated knowledge and use of US, ... working with Global Facilities Delivery, Lilly project staff, Global Computer Systems QA, and selected service provider...mentorship and QA oversight for change management, QRM, process validation and equipment validation efforts. + Works… more
- Sanofi Group (Swiftwater, PA)
- …Swiftwater site, supporting directly the manufacturing system automation computer system validation . As a Computerized Systems Validation Engineer, you ... **Job Title:** Computerized Systems Validation Engineer (CSV) Engineer **Location**...possible. Ready to get started? **Main Responsibilities:** + The Computer System Validation Engineer will be responsible… more