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Investigator 2, Manufacturing

Job Location:

Durham County, NC - USA

Monthly Salary: Not provided by the employer

Posted: 23 July 2026 (30+ days ago)

Application Deadline: 2 December 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

Investigator 2 Manufacturing is responsible to perform investigation for Cell Culture Fermentation and Downstream programs to identify impact for events/minor/major and close PRs within the required standard work timeframe. This role contributes to the creation of effective corrective
and preventative actions (CAPAs) while ensuring timely closure of assigned investigations.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

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

Major Accountabilities:

Able to work on event minor and major investigations with applying site and global compliance SOPs.
Identify and address corrective and preventative actions (CAPAs) based on root cause analysis and ensure they are implemented and effective.
Organize participate in and/or lead cross-functional investigational teams including internal and external (client) members.
Track and analyze performance metrics to identify trends and develop continuous improvement projects.
Participate in Problem Analysis (PA) sessions.
Support document revisions review/ approval of investigation records and participate in quality improvement initiatives.
Prepare storyboards for significant deviations and ability to present to regulatory agencies.
Participate and/or lead difficult discussions to internal team clients and regulatory agencies.
Attend and participate in meetings including tier meeting internal and external client calls team huddles business review meetings and others as needed.
Supports junior investigators regarding investigative techniques and best practices.
Demonstrated knowledge of cGDPs and cGMPs and the requirements to operate in a clinical and commercial manufacturing environment.
Ability to independently prioritize work based on program needs and deviation timelines.

Minimum Requirements:

High School Diploma or Equivalent with 9 years of applicable industry
experience OR
Associates degree with 7 years of applicable industry experience OR
Bachelors degree with 5 years of applicable industry experience OR
Masters degree 3 years of applicable industry experience
Understanding of cGDPs and cGMPs and the requirements to operate in a clinical and commercial manufacturing environment.

Preferred Qualifications:

Understanding of operational excellence and the ability to apply root cause analysis problem solving and continuous improvement methodology.
Strong knowledge of Excel Word and PowerPoint
Root Cause Analysis (RCA) training

Knowledge Skills or Abilities:

Knowledge of change management investigations CAPAs and continuous improvement.
Strong technical writing and facilitation skills.
Ability to effectively lead cross-functional teams during analysis and CAPA discussions.
Ability to identify appropriate casual analysis tool for assigned investigations.
Team based attitude and ability to work in a global team environment and build relationships.
Ability to effectively present information and findings to others.
Effective communication both written and oral.
Knowledge of performance improvement with a basis in Human and Organizational Performance principles.
Ability to analyze and extrapolate data and synthesize and determine recommendations including the analysis of complex problems.
Ability to interpret and document technical information and records from multiple subject matter experts (SMEs) into a coherent clear and concise narrative to support the investigation process.

Physical Requirements:

Ability to stand for prolonged periods of time (120 minutes)
Ability to conduct activities using reptitive motions that include wrists hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 lbs.

EEO Information

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.

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 ().

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Fujifilm

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