Qa Engineer - Digital Technologies

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 us
We 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 solutionsto 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.
External US
Job Responsibilities

• You should expect the role and responsibilities to develop and evolve as the project group expands, and subsequently moves into operations
• Collaborate and align with other FUJIFILM Diosynth Biotechnologies sites
• Perform an SME role within the QA effort for the development of documents, processes, and procedures of the Computer Systems Validation (CSV) program
• Participate in building the QA Digital Technologies Team during the project phase
• Ensure that the Computer System Validation on the project is conducted in a consistently high standard, and that quality objectives are met on time suiting the company's vision and objectives
• Oversight and approval of Manufacturing and IT Computerized Systems lifecycle documentation, including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Opportunities to make periodic International and Domestic travel
• Generate, review, and approve QA procedures for the validation approach and lifecycle documents for Manufacturing and IT Computerized Systems.
• Assess the impact of Computer System modifications and maintain change control
• QA oversight of maintenance of the validated state of Manufacturing and IT Computerized Systems through commercial operation.

Requirements

We are looking for a candidate with the following background and skill sets:

• Driven, self-starter with Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals. Ability to take independent ownership of workstreams.
• Direct CSV experience and/or Quality oversight of these systems, or an equivalent combination of education and experience appropriate to the role will be considered
• Highly collaborative individual with a “can do” attitude and good organizational skills. Proven ability to explain IT/AUT/CSV/QA concepts to non-SME’s
• Excellent oral and written communications skills and fluency in English
• High level of familiarity/understanding of Automation Control Systems, Manufacturing & IT Systems, and methods including ASTME2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11 is required.
• Specific SME experience in Serialization , QC Lab Equipment (Empower, etc) is strongly preferred.
• Understanding of one or more of the following processes:
• Experience in Computer System Validation of Automation and/or IT Applications and Infrastructure, appropriate to an SME level role in an GMP-regulated facility, is required

• Working knowledge of Smartsheet and/or Kneat validation software is a plus
• Large-scale recovery processes
• Finished goods manufacturing
• Formulation and/or fill
• Cross-cultural collaboration is a plus
• Cell culture or fermentation