QA CQV SME IT & Automation in Holly Springs, North Carolina | Careers at NC Holly Springs FDBU Office

We are currently seeking a Quality Assurance CQV SME to join us as we build the largest life science and CDMO facility in the US. This SME role will be a key QA partner for CQV Engineering to assure CQV quality and cGMP compliance for the automation and computer systems for the new green field site and will report to the site QA CQV Lead.

The successful candidate will be able to partner prospectively with CQV Engineering to create efficient and cGMP compliant CQV plans and documents for automation and computer systems. This role provides critical quality assurance oversight for all CQV related documentation and quality assurance partnership for detailed designs for automation and computerized systems.

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 create 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 FDB call Genki.

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 offer the possibility of playing a central role in the Drug Substance Manufacturing Upstream Process Equipment work package in a $2 billion global project. We are looking for expertise in upstream process engineering with experience in production of monoclonal antibodies and expertise in Weigh and Dispense, Media Prep, Cell Culture, Perfusion, Harvest Centrifugation, and/or Depth Filtration.

We are currently seeking a Quality Assurance CQV SME to join us as we build the largest life science and CDMO facility in the US. This SME role will be a key QA partner for CQV Engineering to assure CQV quality and cGMP compliance for the automation and computer systems for the new green field site and will report to the site QA CQV Lead.

The successful candidate will be able to partner prospectively with CQV Engineering to create efficient and cGMP compliant CQV plans and documents for automation and computer systems. This role provides critical quality assurance oversight for all CQV related documentation and quality assurance partnership for detailed designs for automation and computerized systems.

Job Responsibilities include:

• Provide quality assurance partnership with CQV engineers tasked with establishing an efficient and cGMP compliant CQV process for automation and computer systems
• Leverage existing CQV processes, procedures, and documents from other Fujifilm facilities, where possible, to provide efficient, agile, and aligned QA CQV Plan for the project to cover all aspects from conceptual design through to beginning of plant operations
• Assure suitability and cGMP compliance through approvals of FAT, SAT, Commissioning, IQ, OQ and PQ as well as Validation Final Reports, Validation Project Plans, Cleaning Validation documents, Risk Assessments, Traceability Matrices, etc.
• Contribute, as necessary, to QA supplier qualification, audit and approval process as well as operations to support the project
• Provide quality assurance support for detailed design activities for the Drug Product Finished Goods Facility
• Create and maintain reliable concise planning and tracking of assigned responsibilities and functions

Basic Requirements include:

• Bring contagious positive enthusiasm and an agile proactive mindset to quality and cGMP compliance
• Minimum of 8 years CQV Biotech experience on large scale automation and computerized systems projects with desired experience with automation and computerized system detailed design
• Have current knowledge of Biotech automation and computerized systems, GAMP 5, and applicable cGMP requirements as well as a working knowledge of ASTM E2500 / Leveraging Verification process
• Capable of partnering to assure suitability and cGMP compliance of FAT, SAT, Commissioning, IQ, OQ and PQ as well as Validation Final Reports, Validation Project Plan, Annual Validation documents etc.
• Have knowledge of multi product CDMO facilities and their automation and computerized systems
• Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and supporting functions such as CQV, QC, Engineering, Automation and Senior Management
• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills

FDBH 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.

FDBU 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 (see application details).

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.