Job Description
Position Overview Join a high-impact team where your curiosity, problem-solving, and drive to improve will make a tangible difference. As an Investigator I, you'll execute minor internal manufacturing investigations, pinpoint root and contributing causes, and help shape effective corrective and preventive actions (CAPAs) that keep our operations running at their best. You'll also partner with senior investigators on major investigations-gaining exposure, mentorship, and opportunities to grow.
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:
Job Description What You'll Do
- Complete minor internal manufacturing investigations to support DPFG.
- Support senior investigators with major investigations, as needed.
- Develop knowledge and capabilities to perform systematic causal analysis methods (e.g., Event & Causal Factor Analysis, Logic Fault Tree) to identify root and contributing causes.
- Document clear and concise investigation findings and related actions in alignment with Quality Management System (QMS) requirements.
- Participate in the development of CAPAs to support the investigation process.
- Communicate investigation progress and outcomes to impacted areas (including management) and track milestones through closure.
- Manage your investigation workload to ensure closure within required timelines.
- Contribute to metric reports and prepare presentations for senior leadership, as requested by senior investigators or management.
- Participate in performance improvement initiatives grounded in Human and Organizational Performance (HOP) principles.
- Assist with extrapolating and analyzing data; coordinate recommendations that support both minor and major investigations under the direction of senior investigators or a manager.
- Perform other duties, as assigned.
What You'll Bring (Knowledge, Skills, and Abilities)
- Working knowledge of systematic causal analysis methods (e.g., Event & Causal Factor Analysis, Logic Fault Tree).
- Ability to identify and apply the appropriate causal analysis tool for each investigation.
- Strong collaboration skills to work effectively with cross-functional teams during causal analysis and CAPA discussions.
- Solid technical writing skills with the ability to document detailed, accurate, and clear investigation reports.
- Team-first attitude; ability to build relationships and partner with key stakeholders.
- Confident communicator-capable of presenting information and findings to diverse audiences.
- Ability to interpret technical input from multiple SMEs and craft a coherent, concise narrative with support from senior investigators.
Minimum Education and Experience Required
- High School Diploma/GED with 6 years of related experience (e.g., investigations); or
- Associate's degree in Life Sciences or Engineering with 4 years of related experience (e.g., investigations); or
- Bachelor's degree in Life Sciences or Engineering with 2 years of related experience (e.g., investigations); or
- Equivalent Military experience
- Experience in quality or manufacturing operations
Preferred Qualifications
- Experience applying Event & Causal Factor Analysis, Logic Fault Tree, or similar root cause methodologies.
- Prior involvement in CAPA development and effectiveness verification.
- Exposure to Human and Organizational Performance (HOP) principles.
- Experience contributing to investigation metrics and leadership presentations.
- Familiarity with QMS documentation standards.
Why You'll Love It Here
- Make a visible impact by improving processes, preventing recurrence, and elevating quality.
- Grow alongside seasoned investigators and leaders who invest in your development.
- Work on meaningful challenges that blend data, teamwork, and critical thinking.
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.
*#LI-Onsite
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 (
[email protected]).
Job Tags
Full time