Senior Investigator (DSM) - Fujifilm

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 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.

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.

Check out the FDB Holly Springs Site!

About This Role

The Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) is responsible to perform major and critical investigations, determination of root cause, the creation of effective corrective and preventive actions (CAPAs) and ensure on time closure of assigned investigations.

What You’ll Do

During project phase

• Supports the transfer of the deviation management process from the Denmark site.
• Authors standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed.
• Performs any “in operations” duties listed below that are required prior to routine operations.

In operations

• Reviews critical, high-risk internal manufacturing investigations
• Applies systematic methods to conduct investigations.
• Documents investigation findings and related actions in alignment with Quality Management System require-ments
• Leads junior investigators and coordinates tasks, as needed.
• Leads the development of complex and potentially, Global CAPAs
• Collaborates cross-functionally and across sites to maintain alignment on how processes and systems are im-proved due to investigative findings and/or risk analysis.
• Coaches and mentors junior staff on investigative techniques and best practices
• Delivers effective, informative, and engaging presentations regarding metrics, updates, etc. to senior leadership or other stakeholders.
• Other duties, as assigned

Basic Requirements

• High School Diploma/GED with 12 years related experience.

Preferred Requirements

• Associate degree in Life Sciences or Engineering with 10 years of direct experience (e.g., investigations); or
• Bachelor’s degree in Life Sciences or Engineering with 8 years of direct experience (e.g., investigations); or
• Equivalent Military experience
• Prior experience leading complicated manufacturing investigations

• Prior experience in quality or manufacturing operations

• Root cause analysis

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• 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.