Sr. Investigator

Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) 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. 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." Job Description What You'll Do 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 Basic 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 Preferred Requirements RCA training Working Conditions & Physical Requirements Ability to discern audible cues Ability to stand for prolonged periods of time - 30 Minutes Ability to sit for prolonged periods of time - 60 Minutes Ability to conduct work that includes moving objects up to 10 pounds 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 ().

Created: 2026-03-10