FUJIFILM Biotechnologies
Engineer / Scientist 2 (Upstream)
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
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Engineer / Scientist 2
role at
FUJIFILM Biotechnologies
The Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operations.
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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, NC 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
Lead and support technology transfer (TT) sub‑team activities by conducting lab and pilot plant experiments
Collaborate and lead execution of sampling protocols, as directed
Participate in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
Support training of manufacturing staff
Support training members of the process sciences group on the use of equipment in the lab and pilot plant areas
Analyze and summarize lab data for clients
Write process performance qualification (PPQ) protocols and reports
Support and lead TT within unit operation, as directed
Interpret and communicate results to the TT team
Provide technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
Write reports and aid in closing out deviations
Provide process training and consultation on topics related to manufacturing and process
Provide input to technical risk assessments for new manufacturing processes
Contribute to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
Collaborate with the manufacturing department to support commercial and clinical manufacturing campaigns, including on‑floor support
Support continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
Manage lab equipment
Collaborate with colleagues to develop lab scale protocols
Execute and oversee sampling plans for lab runs
Serve as on‑call for lab issues and concerns
Other duties, as assigned
Knowledge & 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 Requirement
Experience working in a Good Manufacturing Practices (GMP) environment
Working Conditions & Physical Requirements
Ability to discern audible cues.
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 (FDBN_PNC@fujifilm.com).
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Engineer / Scientist 2
role at
FUJIFILM Biotechnologies
The Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operations.
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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, NC 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
Lead and support technology transfer (TT) sub‑team activities by conducting lab and pilot plant experiments
Collaborate and lead execution of sampling protocols, as directed
Participate in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
Support training of manufacturing staff
Support training members of the process sciences group on the use of equipment in the lab and pilot plant areas
Analyze and summarize lab data for clients
Write process performance qualification (PPQ) protocols and reports
Support and lead TT within unit operation, as directed
Interpret and communicate results to the TT team
Provide technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
Write reports and aid in closing out deviations
Provide process training and consultation on topics related to manufacturing and process
Provide input to technical risk assessments for new manufacturing processes
Contribute to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
Collaborate with the manufacturing department to support commercial and clinical manufacturing campaigns, including on‑floor support
Support continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
Manage lab equipment
Collaborate with colleagues to develop lab scale protocols
Execute and oversee sampling plans for lab runs
Serve as on‑call for lab issues and concerns
Other duties, as assigned
Knowledge & 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 Requirement
Experience working in a Good Manufacturing Practices (GMP) environment
Working Conditions & Physical Requirements
Ability to discern audible cues.
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 (FDBN_PNC@fujifilm.com).
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