Position Overview

The Associate Investigator assists with and performs minor investigations, root cause analyses, and collaborates cross-functionally. This role ensures the assigned investigations are completed timely and provides support to senior investigators, as needed.

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

Job Description

What You’ll Do

 

Project Phase (Through Mid-2026)

• Assists with revising standard operating procedures (SOPs) and work instructions (Wis) to support operational readiness, as needed• Performs any “in operations” duties listed below that are required prior to routine operations

Operations (Starting Mid-2026)

• Completes minor internal manufacturing investigations to support DSM with direction from senior investigators or management• Assists senior investigators with major investigations, as needed• Develops knowledge and capabilities to perform systematic casual analysis methods to help identify root and contributing causes for assigned investigations• Documents investigation findings and related actions in alignment with Quality Management System requirements• Participates in corrective and preventive action (CAPA) discussions to support the investigation process • Communicates investigation process to impacted areas, including senior investigators and/or management, and tracks milestones throughout the investigation• Organizes and prioritizes investigation workload to ensure closure of minor investigations within required timeline• Assists with preparing metric reports for senior leadership, as requested by senior investigators or management• Other duties, as assigned

 

Basic Requirements

 

• High School Diploma/GED with 4 years of related experience (e.g., investigations); OR• Associate’s degree in Life Sciences or Engineering with 2 years of related experience (e.g., investigations); OR• Equivalent Military experience

 

Preferred Requirements

 

• Bachelor’s degree in Life Sciences or Engineering• Prior experience in a Good Manufacturing Practice (GMP), quality, or manufacturing operations

• Root Cause Analysis (RCA) training• BioWork or BTEC Capstone cGMP coursework

 

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

 

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 (FDBN_PNC@fujifilm.com).