Head of Commissioning, Qualification and Validation

We are looking for a Head of CQV, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. You will be responsible for setting the direction and managing a central workstream in a $2 billion global project.

As the Head of CQV, you will be responsible for the building and leading the CQV team and ensure delivery during all project phases – Design, Document Generation, FAT, Mechanical Completion, Set to Work, Pre Safety Start up Reviews, Commissioning, Qualification and full handover to Operations.

You will be crucial in establishing a culture of collaboration and in facilitating a solution seeking atmosphere and will be expected to be a role model for your future colleagues.

We offer the possibility of leading all field execution and ensure timely ordering of all CQV Spares for the project, prior to commissioning start.

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 will be located in Holly Springs, North Carolina, United States.

We are looking for a Head of CQV, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. You will be responsible for setting the direction and managing a central workstream in a $2 billion global project.

As the Head of CQV, you will be responsible for the building and leading the CQV team and ensure delivery during all project phases – Design, Document Generation, FAT, Mechanical Completion, Set to Work, Pre Safety Start up Reviews, Commissioning, Qualification and full handover to Operations.

You will be crucial in establishing a culture of collaboration and in facilitating a solution seeking atmosphere and will be expected to be a role model for your future colleagues

We offer the possibility of leading all field execution and ensure timely ordering of all CQV Spares for the project, prior to commissioning start.

You will have the responsibility of producing and managing all CQV Costs for the project, not just resources, but also including – Consumables and Spares, Validation Licence's, FAT Costs, Vendor SAT costs, Master Project Database, Rough and Final Balancing of Utilities, Hot Loop and Calibrations, Shift Allowances and any Direct Impact QA Assessments required.  

Additionally, you will represent CQV at PM meetings and Senior Leadership meetings, when required as well as be point contact with Construction Management Team in relation to site readiness and date requirements.

We are looking for a leader 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

• Build and leads the CQV team in the Galaxy project and responsible for the overall deliverables as work package owner 
• Ensure timely ordering of all CQV Spares for Project, prior to Commissioning Start.
• Act as Project SME for all CQV processes, including ASTM E2500, which will be utilized for CQV document creation and field execution 
• Ensure the Team is in place to deliver the project at each phase
• Project manager of the work package securing high quality and on time deliverables 
• Ensure relevant tracking in place for CQV deliverables, both documentation readiness and field execution of protocols and test scripts.  
• Assume overall budget responsibilities for the work package  
• Create and manage all documentation produced for the Project, including Plans, SOPs, Strategies, DQ, QRA, RTM, FAT, RV, SAT, IOC, IOQ and all supporting Final Reports  
• Liaise with all project departments and disciplines to ensure timely resolution of project concerns as they arise
• Prepare and presents project status and targets 

Requirements

Preferred Requirements

• 5+ years in a similar management role for CQV on Large Scale Biotech Projects. 
• Subject Matter Expert on ASTM E2500 / Leveraging Verification process 
• Experience in facility startup from design through to OQ

Basic Requirements

• Master's or Bachelor's degree in Physical, Chemical or Biological Science, Technical Engineering or equivalent  
• Experience in a cGMP facility or working with FDA regulations
• Excellent team development and interpersonal skills
• Excellent communication skills and fluency in English

FDBU 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.

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.