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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

What You’ll Do

Project Phase (Through Mid-2026)

• 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

Operations (Starting Mid-2026)

• 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

Basic 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

Preferred Requirements

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

• Root Cause Analysis (RCA) training

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment operating a motor vehicle or Powered Industrial Truck
• Ability to discern audible cues
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• 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.

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.

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).