Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 14, 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 Genki.Join 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.The Computer Systems Validation (CSV) Engineer is responsible for supporting compliance related to computerized systems via the creation, review, and execution of validation documentation and protocols for IT systems with applicable regulatory and cGMP guidelines.The CSV Engineer will provide IT systems validation and compliance expertise for the various systems across the new site. This position will work within a collaborative team and will be required to have excellent verbal and written communication skills.This position requires basic knowledge of IT infrastructure hardware, software, and FDA regulation 21 CFR Part 11.This position will report directly to the Project Head - Information Technology but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
Keywords: FUJIFILM Holdings America Corporation, Cary , CSV Engineer, Engineering , Holly Springs, North Carolina
here to apply!