**Position Overview** The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production. **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 + Large scale manufacturing support experience with chromatography for several types of chromatographic mediums operations, viral filtration, ultrafiltration, and bulk filling, troubleshooting, and deviation support + 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 in contract manufacturing or interacting with contract manufacturers + 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** Will work in environment which may necessitate respiratory protection X No Yes May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes Ability to discern audible cues. No X Yes Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes Ability to stand for prolonged periods of time. X No Yes Ability to sit for prolonged periods of time. X No Yes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes Ability to operate machinery and/or power tools. X No Yes Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes **Job Locations** _US-NC-Holly Springs_ **Posted Date** _9 hours ago_ _(7/25/2025 1:15 PM)_ **_Requisition ID_** _2025-35180_ **_Category_** _Engineering_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_