QA Engineer - Digital Technologies

Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 17, 2023

Job Description:

Overview









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.













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Job Responsibilities

• Perform an SME role within the QA effort for the development of documents, processes, and procedures of the Computer Systems Validation (CSV) program
• Assess the impact of Computer System modifications and maintain change control
• 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.
• Generate, review, and approve QA procedures for the validation approach and lifecycle documents for Manufacturing and IT Computerized Systems.
• 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
• QA oversight of maintenance of the validated state of Manufacturing and IT Computerized Systems through commercial operation.
• Collaborate and align with other FUJIFILM Diosynth Biotechnologies sites
• Participate in building the QA Digital Technologies Team during the project phase
• Opportunities to make periodic International and Domestic travel
• You should expect the role and responsibilities to develop and evolve as the project group expands, and subsequently moves into operationsRequirementsWe 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.
  • 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
  • Specific SME experience in Serialization, QC Lab Equipment (Empower, etc) is strongly preferred.
  • 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
  • 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.
  • 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
  • Understanding of one or more of the following processes:
    • • cell culture or fermentation
      • large-scale recovery processes
      • formulation and/or fill
      • finished goods manufacturing
      • Cross-cultural collaboration is a plus
      • Working knowledge of Smartsheet and/or Kneat validation software is a plus
        
        
        
        

Keywords: FUJIFILM Holdings America Corporation, Cary , QA Engineer - Digital Technologies, Other , Holly Springs, North Carolina