Investigator 2, Manufacturing

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

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:

Major Accountabilities
:

• 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 Power Point
• 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…