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Sr. Investigator

2 weeks ago

Mount Holly Springs, Pennsylvania, United States Fujifilm Full time
Position Overview

The Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) is responsible to complete major and complex manufacturing investigations, identify root cause, and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors, internal auditors, and senior leadership, as needed regarding the findings of investigations. Additionally, this role mentors and provides guidance to junior investigators throughout the investigation process.

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


• Performs major and complex manufacturing investigations to support DSM
• Applies systematic casual analysis methods to identify root and contributing causes for assigned investigations
• Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements
• Communicates investigation progress to impacted areas, including DSM management
• Collaborates with key stakeholders during the analysis of situations and data, the root cause analysis (RCA) process, and the development of CAPAs to successfully and thoroughly complete manufacturing investigations
• Manages investigation workload, tracks milestones throughout the process, and ensures on-time closure of assigned investigations
• Assigns deviations for the DSM Deviations Management team
• Mentors junior investigators on the investigation process, including the development of the investigation team, use of appropriate RCA tools, and CAPA development
• Leads and participates in process improvement initiatives for the investigation process
• Reviews and creates metric reports for senior leadership
• Delivers effective, informative, and engaging presentations regarding investigations, metrics, etc. to senior leadership or other stakeholders, as needed
• Engages with regulatory inspectors and internal auditors, as needed
• Collaborates cross-functionally and across sites to maintain alignment on process and system improvements due to investigative findings and risk analysis
• Other duties, as assigned

Basic Requirements


• High School Diploma/GED with 12 years related experience (e.g., investigations); OR
• Associate's degree in Life Sciences or Engineering with 10 years of direct experience (e.g., investigations); OR


• Bachelor's degree in Life Sciences or Engineering with 8 years of direct experience (e.g., investigations); OR
• Equivalent Military experience
• Experience in quality or manufacturing operations
• Prior experience leading complex manufacturing investigations

Preferred Requirements


• RCA training

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

  • 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

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.

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 ).