Computer System Validation (CSV) Lead

We are looking for a Computer System Validation (CSV) Lead 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.

In the project phase, your main responsibility as the Computer System Validation (CSV) Lead will be to provide input and set the direction on all GxP Manufacturing and IT Computerized Systems as well as prepare validation documentation for the systems. You will work closely together with the other disciplines in the project and IT/Automation departments at other sites to align strategies and procedures. Once in Operations, you will be responsible for 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 may be involved in facilitating improvement initiatives and supporting regulatory agency and third-party inspections. You will report to the Head of IT & Automation.

External US

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.

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 site is to be located in Holly Springs, North Carolina, United States.

As the Computer System Validation (CSV) Lead, you will have direct impact on the validation of a fully automated $2 billion Greenfield CDMO facility. We offer the possibility of being a part of the IT/Automation Team within the area of Drug Substance Manufacturing (DSM), Drug Product (DP), and Finished Goods Manufacturing (FGM). Your existing experience as a technical SME will be leveraged to educate and motivate others on this exciting project.

We are looking for a team member with positive energy, entrepreneurship, and courage to empower and inspire others while utilize your extensive knowledge and knowhow. You will join an organization focusing on growth, people, and a steep learning curve as well as a diverse workplace with people driven to make a difference.

Job Responsibilities

• Provide plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems
• Lead and take active part in the development of documents, processes, and procedures of the Computer Systems Validation (CSV) program
• Generate, review, and approve 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.
• Maintain the validation status of Manufacturing and IT Computerized Systems through commercial operation.
• Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time suiting the company's vision and objectives
• Collaborate and align with other FUJIFILM Diosynth Biotechnologies sites
• Coordinate with Computer System vendors as needed
• Assess the impact of Computer System modifications and maintain change control
• Participate in building and subsequently leading the CSV 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

Requirements

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

• Bachelor's degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or technical equivalent
• 10+ years' direct Computer System Validation experience in a cGMP Pharmaceutical facility working with FDA regulations
• Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
• Working knowledge of Kneat validation software is a plus
• Excellent oral and written communications skills and fluency in English
• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
• Knowledge with Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing (FGM) required 

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 FDBUHR@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.