Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more importantand 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 peoples 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.

About This Role

The QA Engineer for Quality Control (QC) Compliance will be responsible during the project phase, to help drive the Quality oversight for all QC Laboratory processes, through operational readiness, as well as provide oversight of validation program execution for these processes. This role will also collaborate with other project teams, and with QA departments at other sites to align strategies and procedures. This role and the associated responsibilities will develop as the project matures, and startup activities evolve into operations. This role during operations will continue to ensure that all QC Laboratory systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, as well as QA oversight of day-to-day activities and resolution/mitigation of issues occurring during laboratory operations. Additionally, may participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.

What Youll Do

• Provide QA oversight and support of project deliverables in accordance with governing processes, and procedures for the QC laboratory program.
• Performs as SME role within the QA team for the development of documents, processes, and procedures for the QC laboratory program.
• Assess the impact of system and process modifications and maintain oversight of change management processes to ensure laboratory Systems are first validated, and then maintained in a validated state through site startup and into commercial operations.
• Provide oversight and approval of laboratory system and process lifecycle documentation, including risk and impact assessments, product, processand equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generate, review, and approve QA documentation, procedures, and processes for operational readiness objectives and QA support of laboratory operations in cGMP regulated facility.
• Ensure that project and operational quality objectives are met within desired timelines.
• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Perform other duties as assigned

Minimum Requirements:

• BS/BA in Life Sciences or Engineering or equivalent with 6 years of applicable industry experience
• 3 years of experience in GMP Quality Assurance and/or similar role
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• 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

Preferred Requirements:

• MS in Life Sciences or Engineering and 4 years of applicable experience OR PhD in Life Sciences or Engineering
• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
• Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
• Experience with startup projects or initiatives
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
• Occasional opportunity for International and/or Domestic travel may be available

• Ability to stand for prolonged periods of time up to 30 minutes
  Ability to sit for prolonged periods of time up to 120 minutes
  Ability to conduct work that includes moving objects up to 10 pounds

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 FDBN_PNC@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.