QA Engineer - Digital Technologies
Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 17, 2023
The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call GenkiJoin usWe are growing our locations and are investing more than $2 billion into establishing a new -large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions -to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also -provide -automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.We are looking for a Quality Assurance Engineer, Digital Technologies, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the QA Engineer for Digital Technologies, you will have direct impact on the validation of a fully automated $2 billion Greenfield CDMO facility.In the project phase, your main responsibility as the QA Engineer SME for Digital Technologies will be to help drive the Quality oversight for the direction of all automated GxP Manufacturing and IT Computerized Systems as well as oversight of validation documentation for these systems. You will work closely together with other areas within the project, as well as IT/Automation departments at other sites to align strategies and procedures. Once in operations, you will assist the Quality partnership in ensuring that all GxP Manufacturing and IT Computerized Systems are maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. Additionally, you will participate in improvement initiatives and support regulatory agency and third-party inspections. You will report to the QA Lead Engineer for Digital Technologies.
Keywords: FUJIFILM Holdings America Corporation, Cary , QA Engineer - Digital Technologies, Other , Holly Springs, North Carolina
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