Sr. Investigator

Fujifilm•Holly Springs, NC

About The Position

The Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) 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 FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

High School Diploma/GED with 12 years related experience (e.g., investigations); 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

Nice To Haves

RCA training

Responsibilities

Performs major and complex manufacturing investigations to support DSM
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 DSM 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 DSM 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