Job Information
Fujifilm Senior Investigator, Drug Product in Holly Springs, North Carolina
Position Overview
The Senior Investigator of Deviations Management for Drug Product Finished Goods (DPFG) is responsible to complete major and complex manufacturing investigations, identify root cause, and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors, internal auditors, and senior leadership, as needed regarding the findings of investigations. Additionally, this role mentors and provides guidance to junior investigators throughout the investigation process.
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.
Job Description
What You’ll Do
Project Phase (Through Mid-2025)
• 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
Operations (Starting Mid-2025)
• Performs major and complex manufacturing investigations to support DPFG
• Applies systematic casual analysis methods to identify root and contributing causes for assigned investigations
• Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements
• Communicates investigation progress to impacted areas, including DPFG management
• Collaborates with key stakeholders during the analysis of situations and data, the root cause analysis (RCA) process, and the development of CAPAs to successfully and thoroughly complete manufacturing investigations
• Manages investigation workload, tracks milestones throughout the process, and ensures on-time closure of assigned investigations
• Assigns deviations for the DPFG Deviations Management team
• Mentors junior investigators on the investigation process, including the development of the investigation team, use of appropriate RCA tools, and CAPA development
• Leads and participates in process improvement initiatives for the investigation process
• Reviews and creates metric reports for senior leadership
• Delivers effective, informative, and engaging presentations regarding investigations, metrics, etc. to senior leadership or other stakeholders, as needed
• Engages with regulatory inspectors and internal auditors, as needed
• Collaborates cross-functionally and across sites to maintain alignment on process and system improvements due to investigative findings and risk analysis
• Other duties, as assigned
Basic Requirements
• High School Diploma/GED with 12 years related experience; OR
• Associate’s 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
• Experience in quality or manufacturing operations
• Prior experience leading complex manufacturing investigations
Preferred Requirements
• Root Cause Analysis (RCA) training
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to discern audible cues
Ability to stand for prolonged periods of time - Up to 30 Minutes
Ability to sit for prolonged periods of time - Up to 60 Minutes
Ability to conduct work that includes moving objects up to 10 pounds
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.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
Job Locations US-NC-Holly Springs
Posted Date 7 days ago (4/9/2025 9:35 AM)
Requisition ID 2025-34214
Category Manufacturing
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies