FUJIFILM Biotechnologies
Sr Engineer 2/Scientist 2 (Upstream)
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
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 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.”
Job Description The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.
What You’ll Do
Develop site technical training programs for new processes and procedures
Collaborate with cross‑functional teams to support commercial and clinical manufacturing campaigns, including on‑floor support
Lead continuous improvement projects in partnership with Manufacturing, Quality, Engineering, Global teams to improve manufacturability, reliability, yield, and cost
Serve as SME to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
Provide supplier technical evaluations, risk assessments, raw material evaluation and qualification, and experimental plans as required
Identify opportunities to improve systems and practices and provide direction to local and global cross‑functional teams
Lead one or more projects spanning multiple departments and cross‑functional areas
Provide engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
Lead process sub‑teams throughout the phases of TT
Develop project plans, timelines, and communication forums to ensure a smooth transfer
Lead troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
Lead the execution of all aspects of process validation including ancillary process validation (both at‑scale and small‑scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
Write, review, and approve master batch records (MBRs) and standard operating procedures (SOPs)
Lead generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
Generate and execute process training and consult on topics related to manufacturing and process
Lead and facilitate technical risk assessments for new manufacturing processes
Provide interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
Lead and coordinate analysis of manufacturing process performance and reporting to manufacturing management
Support development of longer‑term Large‑Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
Deliver documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
Other duties as assigned
Basic Requirements
Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or PhD with 5 years of experience
Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
Experience with facilitating and training others on RCA and risk assessment
Project Management experience
Preferred Requirements
Experience working in a Good Manufacturing Practices (GMP) environment
Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings
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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Job Description The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.
What You’ll Do
Develop site technical training programs for new processes and procedures
Collaborate with cross‑functional teams to support commercial and clinical manufacturing campaigns, including on‑floor support
Lead continuous improvement projects in partnership with Manufacturing, Quality, Engineering, Global teams to improve manufacturability, reliability, yield, and cost
Serve as SME to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
Provide supplier technical evaluations, risk assessments, raw material evaluation and qualification, and experimental plans as required
Identify opportunities to improve systems and practices and provide direction to local and global cross‑functional teams
Lead one or more projects spanning multiple departments and cross‑functional areas
Provide engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
Lead process sub‑teams throughout the phases of TT
Develop project plans, timelines, and communication forums to ensure a smooth transfer
Lead troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
Lead the execution of all aspects of process validation including ancillary process validation (both at‑scale and small‑scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
Write, review, and approve master batch records (MBRs) and standard operating procedures (SOPs)
Lead generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
Generate and execute process training and consult on topics related to manufacturing and process
Lead and facilitate technical risk assessments for new manufacturing processes
Provide interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
Lead and coordinate analysis of manufacturing process performance and reporting to manufacturing management
Support development of longer‑term Large‑Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
Deliver documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
Other duties as assigned
Basic Requirements
Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or PhD with 5 years of experience
Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
Experience with facilitating and training others on RCA and risk assessment
Project Management experience
Preferred Requirements
Experience working in a Good Manufacturing Practices (GMP) environment
Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings
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).
#J-18808-Ljbffr