Manufacturing Investigator II — CAPA & Continuous Improvement

FUJIFILM Electronic Materials (Europe) N.V.; North Carolina; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical coverage

401(k) plan

Paid vacation

Sick time

Job summary

FUJIFILM Biotechnologies is seeking an Investigator 2, Manufacturing to perform investigations across Cell Culture, Fermentation, and Downstream programs, closing PRs within standard timeframes. You will contribute to CAPAs and ensure timely closure while adhering to cGDPs and cGMPs in a clinical and commercial manufacturing environment.

The role requires strong analytical skills, cross-functional collaboration, and the ability to present findings to regulatory bodies and clients within a global

Qualifications

• Experience in investigations of events and CAPAs in cGDP/cGMP environments.
• Ability to lead cross-functional investigation teams and document findings clearly.
• Proficient technical writing and facilitation skills.

Responsibilities

• Perform investigations for event, minor, and major deviations.
• Identify and implement CAPAs with root cause analysis.
• Lead cross-functional teams including internal and client members.
• Track performance metrics and drive continuous improvement.
• Prepare stories for regulatory agencies and close investigations.

Skills

CAPA knowledge

Root Cause Analysis

Technical writing

Communication

Education

High School Diploma

Associate’s degree

Bachelor’s degree

Master’s degree

Tools

Excel

Word

PowerPoint

Job description

FUJIFILM Biotechnologies is seeking an Investigator 2, Manufacturing to perform investigations across Cell Culture, Fermentation, and Downstream programs, closing PRs within standard timeframes. You will contribute to CAPAs and ensure timely closure while adhering to cGDPs and cGMPs in a clinical and commercial manufacturing environment.

The role requires strong analytical skills, cross-functional collaboration, and the ability to present findings to regulatory bodies and clients within a global