**Position Overview** The Engineer/Scientist 3 will provide technology transfer support and technical oversight during manufacturing operations. **Job Description** **What You’ll Do** + Conducts lab and pilot plant experiments + Generates and coordinates execution sampling protocols + Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations + Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems + Leads and supports technology transfer (TT) across multiple unit operation + Coordinates, plans, and executes manufacturing process validation runs + Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations + Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed + Generates and executes process training and consults on topics related to manufacturing and process + Leads technical risk assessments for new manufacturing processes + Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification + Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc. + Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab + Interprets and utilizes new knowledge to promptly drive data-based decisions + Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support + Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost + Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification + Other duties, as assigned **Knowledge and Skills** + Proficient knowledge in Design of Experience (DOE) + Proficient knowledge in Statistical Process Control + Effective communication, both written and oral + Ability to effective present information to others + Proficient project management skills + Advanced problem-solving skills + Ability to provide feedback to others, including leaders + Ability to develop effective working relationships internally and externally + Ability to adapt communication style to differing audiences and advise others on difficult matters **Basic Requirements** + Associate degree in Engineering, Life Science or Chemical Engineering with 8 years related work experience (e.g., manufacturing); or + Bachelor’s degree in in Engineering, Life Science or Chemical Engineering with 6 years of related work experience (e.g., manufacturing) + Master’s degree with 3 years of related work experience; or + PhD with no prior experience + Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system) + Experience using risk management and RCA tools **Preferred Requirements** + Experience working in a Good Manufacturing Practices (GMP) environment + Prior drug substance and manufacturing experience, including process development, validation, and transfer **WORKING 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._ **Job Locations** _US-NC-Holly Springs_ **Posted Date** _6 days ago_ _(12/18/2025 9:57 AM)_ **_Requisition ID_** _2025-35792_ **_Category_** _Engineering_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_