Investigator 2, Manufacturing

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Our site is situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

About the role

As an Investigator 2 in Manufacturing, you will perform investigations for Cell Culture, Fermentation, and Downstream programs to identify impact for events, minor, and major deviations, and close PRs within the required standard work timeframe. This role contributes to the creation of effective corrective and preventative actions (CAPAs) while ensuring timely closure of assigned investigations.

Responsibilities

• Work on event, minor, and major investigations applying site and global compliance SOPs.
• 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 present findings to regulatory agencies.
• Participate and/or lead difficult discussions with internal teams, clients, and regulatory agencies.
• Attend and participate in meetings, including tier meetings, internal and external client calls, team huddles, and business review meetings.
• Support junior investigators regarding investigative techniques and best practices.
• Demonstrate knowledge of cGDPs and cGMPs and the requirements to operate in a clinical and commercial manufacturing environment.
• Independently prioritize work based on program needs and deviation timelines.

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 with 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 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 causal analysis tools for assigned investigations.
• Team-based attitude and ability to work in a global team environment and build relationships.
• 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, 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 repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.

Benefits

• Robust benefits package including medical, dental, vision, and prescription drug coverage with the option of a Health Savings Account with company contributions.
• Industry-leading 401(k) savings plan.
• Insurance coverage, employee assistance programs, and various wellness incentives.
• Paid vacation time, sick time, and company holidays.
• Supportive environment that enriches both personal and professional growth.