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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.
Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!
Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70000 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: Description
What Youll 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
Associates degree in Life Sciences or Engineering with 7 years of related experience (e.g. investigations); OR
Bachelors 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
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 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 committedto 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 ().
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