Investigator 2, Manufacturing

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical coverage

401(k) plan

Paid time off

Wellness incentives

Job summary

FUJIFILM Biotechnologies is seeking an Investigator 2, Manufacturing to conduct CAPA-driven investigations across Cell Culture, Fermentation, and Downstream programs, ensuring timely closure of events and adherence to quality systems. You will lead cross-functional teams, analyze trends, and prepare regulatory-ready narratives.

The role requires strong problem-solving, technical writing, and communication skills, with experience in cGDPs, cGMPs, and a clinical-to-commercial manufacturing

Qualifications

• Nine+ years of industry experience with relevant investigations or CAPA programs
• Understanding of cGDPs and cGMPs and working in clinical and commercial manufacturing environments

Responsibilities

• Perform event, minor and major investigations following site and global SOPs
• Identify and implement CAPAs based on root cause analysis
• Lead cross-functional investigational teams including client members
• Track metrics to identify trends and support continuous improvement projects
• Prepare and present investigations to regulators as needed
• Support document revisions and approvals for investigation records
• Provide guidance to junior investigators on investigative techniques and best practices

Skills

Investigation leadership

Cross-functional collaboration

Root cause analysis

Data analysis

Technical writing

Communication skills

Education

High School Diploma or equivalent (9 yrs exp)

Associate’s degree (7 yrs exp)

Bachelor’s degree (5 yrs exp)

Master’s degree (3 yrs exp)

Tools

Excel

Word

PowerPoint

Job description

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 (CAPA’s) while ensuring timely closure of assigned investigations.

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s 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, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s 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 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: https://www.fujifilm.com/us/en/about/region/careers

Major Accountabilities

Job Description

• Able to work on event, minor and major investigations with applying site and global compliance SOP’s.
• 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
• Associate’s degree with 7 years of applicable industry experience OR
• Bachelor’s degree with 5 years of applicable industry experience OR
• Master’s 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.

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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 ([e-mail]).