Engineer Scientist 2 (Upstream) at Fujifilm

Position OverviewThe Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operationsCompany OverviewFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof. Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together! Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70000 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: DescriptionWhat Youll DoLeads 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 assigned Knowledge and SkillsAbility 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 RequirementsAssociate degree in Engineering Life Science or Chemical Engineering with 4 years of related work experience (e.g. manufacturing); orBachelors degree in Engineering Life Science or Chemical Engineering with 2 years of related work experience (e.g. manufacturing); or Masters 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 REQUIREMENTSAbility 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 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 committedto 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 (). Key Skills Laboratory Experience,Immunoassays,Machine Learning,Biochemistry,Assays,Research Experience,Spectroscopy,Research & Development,cGMP,Cell Culture,Molecular Biology,Data Analysis Skills Employment Type : Unclear Experience: years Vacancy: 1