Investigator 2, Manufacturing

FUJIFILM Healthcare Americas Corporation; Milwaukee (WI); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid vacation

Office holidays

Job summary

FUJIFILM Biotechnologies is seeking an Investigator 2, Manufacturing to perform investigations for Cell Culture, Fermentation and Downstream programs. You will lead CAPA activities, collaborate with cross-functional teams, and prepare regulatory-facing storyboards to support deviations and investigations.

The role emphasizes timely closure of investigations, effective technical writing, and strong data-driven decision making in a GMP manufacturing environment.

Qualifications

• Minimum experience as stated: HS 9 yrs, Associate 7 yrs, Bachelor 5 yrs, Master 3 yrs.
• Understanding of cGDPs and cGMPs in clinical and commercial manufacturing.
• Strong knowledge of Excel, Word and PowerPoint.

Responsibilities

• Investigate events across Cell Culture, Fermentation and Downstream programs and close PRs within required timeframe.
• Identify and implement CAPAs based on root cause analysis and ensure effectiveness.
• Lead cross-functional investigational teams including internal and client members.
• Track performance metrics to identify trends and drive continuous improvement projects.
• Prepare storyboards for deviations and present findings to regulatory agencies.

Skills

Investigation leadership

CAPA

Root Cause Analysis

Cross-functional teamwork

Technical writing

Effective presentation

Data analysis

Communication

Education

High School Diploma or Equivalent

Associate’s degree

Bachelor’s degree

Master’s degree

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]).