QA Engineer - DSM

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 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, Drug Substance Manufacturing (DSM), 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 DSM, you will directly impact the validation and start-up of a fully automated $2 billion Greenfield CDMO facility.

During the project phase, the QA Engineer for DSM will be responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes through to operational readiness, as well as provide oversight of validation program execution for these processes. You will collaborate with other project teams, and with QA departments at other sites to align strategies and procedures.

Once in operations, you will continue to ensure that all DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Additionally, you will participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.

You will report to the QA Lead Engineer for DSM.

External US

Job Responsibilities

• Perform an SME role within the QA team for the development of documents, processes, and procedures for the DSM program
• Assess the impact of system and process modifications and maintain oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation
• Provide oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment 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 Systems
• Generate, review, and approve QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Ensure that project and operational quality objectives are met within desired timelines.
• Actively seek opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency

Requirements

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

• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
• BS in Life Sciences or Engineering and minimum 8 years of experience in GMP quality assurance and/or similar role.
• MS in Life Sciences or Engineering and minimum 6 years of experience in GMP quality assurance and/or similar role.
• High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 required
• Excellent oral and written communications skills and fluency in English

Preferred

• Working knowledge of ASTM E2500, Smartsheet and/or Kneat validation software is a plus
• Understanding of one or more of the following processes preferred:
  • cell culture or fermentation
  • large-scale recovery processes
  • formulation and/or fill
  • finished goods manufacturing
• Occasional opportunity for International and/or Domestic travel may be available
• Training and/or familiarity with Quality Risk Management principles preferred

FDBN works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email lena.lee@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any  kind will be paid.