Sr EngineerScientist 2 (Upstream) at Fujifilm

Position OverviewThe Senior Engineer/Scientist 2 will serve as a subject matter expert and 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 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 DoDevelops site technical training programs for new processes and proceduresCollaborates with cross-functional teams to support commercial and clinical manufacturing campaigns including on-floor supportLeads continuous improvement projects in partnership with Manufacturing Quality Engineering Global teams when applicable to improve manufacturability reliability yield and costServes as subject matter expert (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 changesAs technical SME provides supplier technical evaluations risk assessments raw material evaluation and qualification and experimental plans as requiredIdentifies opportunities to improve systems and practices and provides direction to local and global cross-functional teamsLeads one or more projects spanning multiple departments and cross-functional areasProvides engineering and scientific leadership to support program design capital expenditure (CAPEX) and clinical or commercial processesLeads process sub-teams throughout the phases of TTDevelops project plans timelines and communication forums to ensure a smooth transferLeads troubleshooting process impact assessments and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviationsLeads 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 reportsWrites reviews and approves master batch records (MBRs) and standard operating procedures (SOPs)As technical SME leads generation of master plans contamination control strategy extractable and leachable assessment and other site procedures and policiesGenerates and executes process training and consults on topics related to manufacturing and processLeads and facilitates technical risk assessments for new manufacturing processesProvides interpretation of manufacturing data with advanced statistical techniques to interpret trending and resolve investigationsLeads and coordinates analysis of manufacturing process performance and reporting to manufacturing managementSupports 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 teamDelivers documentation for internal and external use such as comprehensive written manufacturing protocols and reports PPQ protocol and reports summarizing investigations impact assessments studies and projectsOther duties as assignedBasic RequirementsBachelors degree in in Engineering Life Science or Chemical Engineering with 12 years of relevant experience (e.g. manufacturing); orPhD with 5 years of experienceExperience using quality systems (e.g. deviation management system change control CAPA document management system)Experience with facilitating and training others on RCA and risk assessmentProject Management experiencePreferred RequirementsExperience working in a Good Manufacturing Practices (GMP) environmentPrior drug substance or manufacturing experience including process validation transfer commercialization and manufacturing support and troubleshootingExperience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sectionsPrior authorship of Chemistry Manufacturing and Control (CMC) sections for regulatory findingsWORKING CONDITIONS & PHYSICAL REQUIREMENTSAbility to discern audible cuesTo 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 ().Required Experience:Senior IC 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