The Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operations

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

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

What You’ll Do

• Leads and supports technology transfer (TT) sub-team activities by conducting lab and pilot plant experiments
• Collaborates and leads execution of sampling protocols, as directed
• Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
• Supports training of manufacturing staff
• Supports training members of the process sciences group on the use of equipment in the lab and pilot plant areas
• Analyzes and summarizes lab data for clients
• Writes process performance qualification (PPQ) protocols and reports
• Supports and leads TT within unit operation, as directed
• Interprets and communicates results to the TT team
• Provides technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
• Writes reports and aids in closing out deviations
• Provides process training and consultation on topics related to manufacturing and process
• Provides input to technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Supports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Manages lab equipment
• Collaborates with colleagues to develop lab scale protocols
• Executes and oversees sampling plans for lab runs
• Serves as on-call for lab issues and concerns
• Other duties, as assigned

Knowledge and Skills

• Ability to develop effective working relationships internally and externally
• Effective communication, both written and oral
• Ability to provide feedback to others, including leaders
• Strong problem-solving skills
• Project management skills
• Ability to effectively present information to others
• Ability to provide standard professional advice and to create reports and analyses for review

Basic Requirements

• Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g.,
  manufacturing); or
• Master’s degree with no prior experience
• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)

Preferred Requireme

• Experience working in a Good Manufacturing Practices (GMP) environment

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues. 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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.

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 (FDBN_PNC@fujifilm.com).