The Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operations
Company OverviewFUJIFILM 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 experimentsCollaborates 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 staffSupports training members of the process sciences group on the use of equipment in the lab and pilot plant areasAnalyzes and summarizes lab data for clientsWrites process performance qualification (PPQ) protocols and reportsSupports and leads TT within unit operation, as directedInterprets and communicates results to the TT teamProvides technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviationsWrites reports and aids in closing out deviationsProvides process training and consultation on topics related to manufacturing and processProvides input to technical risk assessments for new manufacturing processesContributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigationsCollaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor supportSupports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and costManages lab equipmentCollaborates with colleagues to develop lab scale protocolsExecutes and oversees sampling plans for lab runsServes as on-call for lab issues and concernsOther duties, as assignedKnowledge and Skills
Ability to develop effective working relationships internally and externallyEffective communication, both written and oralAbility to provide feedback to others, including leadersStrong problem-solving skillsProject management skillsAbility to effectively present information to othersAbility to provide standard professional advice and to create reports and analyses for reviewBasic Requirements
Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); orBachelor’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 experienceExperience using quality systems (e.g., deviation management, change control, CAPA, document management system)
Preferred Requireme
Experience working in a Good Manufacturing Practices (GMP) environmentWORKING 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.
EEO InformationFujifilm 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 InformationIf 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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