Investigator 2
Position Overview:
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.
Company Overview:
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business.This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services.The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Job Description:
What You’ll Do
Project Phase (Through Mid-2025)- 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
- 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
- Experience with systematic cause analysis methods (e.g., Event & Casual Factor Analysis, Logic Fault Tree, or similar techniques)
- Root Cause Analysis (RCA) training
- 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 - 30 Minutes
- Ability to sit for prolonged periods of time - 60 Minutes
- Ability to conduct work that includes moving objects up to 10 pounds
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.
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).