FUJIFILM Biotechnologies
Engineer/Scientist 3
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
Job Description
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 effectively 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 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. Seniority Level
Mid-Senior level Employment Type
Full-time Job Function
Engineering and Information Technology
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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 effectively 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 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. Seniority Level
Mid-Senior level Employment Type
Full-time Job Function
Engineering and Information Technology
#J-18808-Ljbffr