Sr. Investigator

Position Overview The Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) is responsible to complete major and complex manufacturinginvestigations, 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 juniorinvestigators throughout the investigation process. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, weu2019ll open North Americau2019s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. Weu2019re 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 weu2019re proud to cultivate a culture that will fuel your purpose, energy, and driveu2014what we call Genki. Ready to shape the future of medicine? Letu2019s transform healthcare together Holly Springs, North Carolina, combines small-town warmth with proximity to Raleighu2019s 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 u201cgiving our world more smiles.u201d Visit: Job Description What Youu2019ll Do u2022 Performs major and complex manufacturing investigations to support DSM u2022 Applies systematic casual analysis methods to identify root and contributing causes for assigned investigations u2022 Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements u2022 Communicates investigation progress to impacted areas, including DSM management u2022 Collaborates with key stakeholders during the analysis of situations and data, the root cause analysis (RCA) process, and thedevelopment of CAPAs to successfully and thoroughly complete manufacturing investigations u2022 Manages investigation workload, tracks milestones throughout the process, and ensures on-time closure of assigned investigations u2022 Assigns deviations for the DSM Deviations Management team u2022 Mentors junior investigators on the investigation process, including the development of the investigation team, use of appropriate RCAtools, and CAPA development u2022 Leads and participates in process improvement initiatives for the investigation process u2022 Reviews and creates metric reports for senior leadership u2022 Delivers effective, informative, and engaging presentations regarding investigations, metrics, etc. to senior leadership or otherstakeholders, as needed u2022 Engages with regulatory inspectors and internal auditors, as needed u2022 Collaborates cross-functionally and across sites to maintain alignment on process and system improvements due to investigative findingsand risk analysis u2022 Other duties, as assigned Basic Requirements u2022 High School Diploma/GED with 12 years related experience (e.g.,investigations); OR u2022 Associateu2019s degree in Life Sciences or Engineering with 10 years ofdirect experience (e.g., investigations); OR u2022 Bacheloru2019s degree in Life Sciences or Engineering with 8 years ofdirect experience (e.g., investigations); OR u2022 Equivalent Military experience u2022 Experience in quality or manufacturing operations u2022 Prior experience leading complex manufacturing investigations Preferred Requirements u2022 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 _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 (). Job Locations _US-NC-Holly Springs_ Posted Date _9 hours ago_ _(12/30/2025 1:13 PM)_ _Requisition ID_ _2025-36586_ _Category_ _Manufacturing_ _Company (Portal Searching)_ _FUJIFILM Biotechnologies_

Created: 2026-01-01