Investigator 2

Fujifilm•Holly Springs, NC

12d

About The Position

The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators. 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.”

Requirements

High School Diploma/GED with 9 years of related experience (e.g., investigations); OR
Associate’s degree in Life Sciences or Engineering with 7 years of related experience (e.g., investigations); OR
Bachelor’s degree in Life Sciences or Engineering with 5 years of related experience (e.g., investigations); OR
Equivalent Military experience
Experience in quality or manufacturing operations
Prior experience leading manufacturing investigations

Nice To Haves

Experience with systematic cause analysis methods (e.g., Event & Casual Factor Analysis, Logic Fault Tree, or similar techniques)
Root Cause Analysis (RCA) training

Responsibilities

Authors standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed
Performs “in operations” duties listed below as required prior to routine operations
Completes major internal manufacturing investigations to support DSM
Supports senior investigators with complex investigations, as needed
Applies systematic casual analysis methods to identify root and contributing cases for assigned investigations
Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements
Communicates investigation process to impacted areas, including management, and tracks milestones throughout the investigations
Partners with key stakeholders during the development of CAPAs to support the investigation process
Manages investigation workload to ensure closure of investigations within required timeline
Supports senior investigators during assignment of workload for DSM Deviations Management team, as needed
Contributes to metric reports to prepare presentations for senior leadership
Delivers informative and engaging presentations regarding metrics and other relevant information to required stakeholders, as needed
Provides guidance to junior investigators regarding investigative techniques and best practices
Other duties, as assigned