Sr Engineer / Scientist 2

Position Overview The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations. Job Description What Youu2019ll Do u2022 Develops site technical training programs for new processes and procedures u2022 Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support u2022 Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost u2022 Serves 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 changes u2022 As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required u2022 Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams u2022 Leads one or more projects spanning multiple departments and cross-functional areas u2022 Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes u2022 Leads process sub-teams throughout the phases of TT u2022 Develops project plans, timelines, and communication forums to ensure a smooth transfer u2022 Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations u2022 Leads 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 u2022 Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs) u2022 As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies u2022 Generates and executes process training and consults on topics related to manufacturing and process u2022 Leads and facilitates technical risk assessments for new manufacturing processes u2022 Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations u2022 Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management u2022 Supports 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 u2022 Delivers 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 u2022 Other duties, as assigned Basic Requirements u2022 Bacheloru2019s degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or u2022 PhD with 5 years of experience u2022 Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system) u2022 Experience with facilitating and training others on RCA and risk assessment u2022 Project Management experience Preferred Requirements u2022 Experience working in a Good Manufacturing Practices (GMP) environment u2022 Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting u2022 Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections u2022 Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings WORKING CONDITIONS & PHYSICAL REQUIREMENTS u2022 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._ Job Locations _US-NC-Holly Springs_ Posted Date _2 days ago_ _(12/1/2025 11:57 AM)_ _Requisition ID_ _2025-36262_ _Category_ _Process Sciences_ _Company (Portal Searching)_ _FUJIFILM Biotechnologies_

Created: 2025-12-04