Manufacturing Investigator II – CAPA & Cross‑Functional Lead

FUJIFILM; North Carolina; On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401(k) savings plan

Paid vacation & holidays

Employee assistance programs

Job summary

FUJIFILM Biotechnologies in North Carolina seeks an Investigator 2, Manufacturing to perform investigations across Cell Culture, Fermentation and Downstream programs. You will drive CAPA development and ensure timely closure under cGMP/cGDP requirements, while coordinating with cross-functional teams and external clients.

The role emphasizes root cause analysis, technical writing, data interpretation, and presenting findings to regulatory agencies.

Qualifications

• Knowledge of cGDPs and cGMPs in clinical and commercial manufacturing.
• Experience with CAPA processes and investigations.
• Strong technical writing and record-keeping abilities.
• Ability to lead cross-functional teams through analysis and CAPA discussions.
• Proficient data analysis and ability to present findings to regulatory bodies.

Responsibilities

• Perform events, minor and major investigations per site and global SOPs.
• Identify and implement corrective and preventive actions (CAPAs).
• Lead cross-functional investigational teams including clients when needed.
• Track metrics to identify trends and drive continuous improvement.
• Prepare storyboards for deviations and present to regulators.

Skills

CAPA management

Root cause analysis

Cross-functional teamwork

Regulatory knowledge

Technical writing

Project collaboration

Education

Bachelor's degree in life sciences

Master's degree in related field

Associate's degree

HS Diploma + 9 years experience

Tools

Excel

Word

PowerPoint

Job description

FUJIFILM Biotechnologies in North Carolina seeks an Investigator 2, Manufacturing to perform investigations across Cell Culture, Fermentation and Downstream programs. You will drive CAPA development and ensure timely closure under cGMP/cGDP requirements, while coordinating with cross-functional teams and external clients.

The role emphasizes root cause analysis, technical writing, data interpretation, and presenting findings to regulatory agencies.