QA Lead Operations Engineer - DPFG

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 Lead Engineer, Drug Product/Finished Goods Manufacturing (DPFG), 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 Lead Engineer DPFG, 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 Lead for DPFG will be to drive the Quality oversight for the direction of all Drug Product and Finished Goods related processes, as well as oversight of validation program documentation and execution for these processes. You will collaborate closely with other areas within the project, as well as QA departments at other sites, to align strategies and procedures.

Once in operations, you will lead the Quality partnership responsible for ensuring that all DPFG systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration and QA oversight of day-to-day activities. Additionally, you will participate in improvement initiatives and support regulatory agency and third-party inspections.

External US

Job Responsibilities

• Lead the QA effort for the development of documents, processes, and procedures for the DPFG manufacturing area
• Assess the impact of system and process modifications and maintain change control
• Review and approve system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, trace 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
• Generate, review, and approve QA documentation, procedures, and processes for QA support of cGMP regulated manufacturing operations
• Ensure that the equipment and process validation on the project is conducted to 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 Systems through commercial operation
• Actively seek opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites
• Building and leading the QA Operations Team (DPFG) during the project phase and into site operations
• You should expect the role and responsibilities to develop and evolve as the project group expands, and subsequently moves into operations

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
• Education and experience appropriate to a team leader for Quality Validation, cGMP manufacturing operations, and/or Quality oversight in an FDA regulated facility, or an equivalent combination of education and experience
• 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, Part 11, and Annex1 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 or large-scale recovery processes
      • formulation and/or fill
      • laminar flow isolator operations/processes
      • finished goods manufacturing

• Training and/or familiarity with Quality Risk Management principles preferred
• Opportunities to make periodic International and Domestic travel

The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.

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.