Process Engineer, MSAT
About The Position
FUJIFILM Biosciences is hiring a Process Engineer, MSAT to develop, scale, transfer, troubleshoot, and improve manufacturing processes in support of safe, compliant, reliable, and repeatable production. The role leads process studies, test batches, and technical investigations, then translates technical findings into effective process controls and manufacturing solutions. The engineer leads cross-functional technology transfers for new and modified products and processes, assesses readiness and risk, prepares transfer documentation, and supports knowledge transfer and transition to routine manufacturing. The role also leads process development, characterization, scale-up, optimization, engineering studies, and test batches; applies engineering and statistical methods to assess process performance; and documents findings and implementation plans. The position leads or supports investigations into manufacturing issues, develops corrective actions and monitoring plans, and provides technical support during manufacturing events and process start-ups. It also supports formulation feasibility and manufacturability assessments, equipment qualification and validation activities, training, and change control in collaboration with Manufacturing, Formulation Sciences, Packaging Engineering, Quality, Validation, R&D/Product Development, Supply Chain, and the Prototype Laboratory. Other engineering-related duties may be assigned as needed.
Requirements
- Bachelor of Science in Chemical Engineering or a related engineering discipline.
- At least 5 years of relevant process engineering experience.
- Required experience in manufacturing process development, characterization, scale-up, technology transfer, or technical investigations.
- Working knowledge of cGMP requirements, FDA regulations, validation, change control, deviations, CAPA, and controlled technical documentation.
- Experience in technology transfer, process development, characterization, scale-up, and test-batch execution.
- Knowledge of process controls, operating-range development, manufacturing readiness, and lifecycle support.
- Proficiency in statistical analysis, process capability assessment, process trending, and data interpretation.
- Experience applying root-cause analysis, risk assessment, FMEA, and structured problem-solving methodologies.
- Ability to translate technical data into practical manufacturing recommendations, controls, specifications, and implementation plans.
- Demonstrated leadership of cross-functional technical projects and manufacturing improvement initiatives.
- Strong technical writing, communication, collaboration, and project-management skills; proficiency with Microsoft 365 applications.
- Ability to speak, read, and write in English.
- Good oral and written communication skills.
Nice To Haves
- Advanced degree preferred.
- Experience in liquid and powder manufacturing preferred.
- Experience in regulated industries preferred.
Responsibilities
- Lead cross-functional technology transfers for new and modified products and manufacturing processes.
- Assess transfer readiness, risks, technical gaps, site requirements, deliverables, and acceptance criteria.
- Prepare and review transfer documentation, technical reports, manufacturing instructions, and supporting records.
- Support knowledge transfer, execution, issue resolution, and transition to routine manufacturing.
- Lead process development, characterization, scale-up, optimization, and manufacturing-readiness activities.
- Define study objectives, hypotheses, risks, success criteria, and data requirements.
- Design and execute engineering studies and test batches evaluating process parameters, material interactions, equipment effects, operating ranges, and controls.
- Apply engineering and statistical methods to evaluate process capability, variability, yield, quality, and scale-related risks.
- Translate study results into process controls, specifications, operating ranges, implementation plans, and risk mitigations.
- Author protocols, study plans, reports, specifications, manufacturing instructions, and other controlled technical documents.
- Lead or support technical investigations involving deviations, process failures, adverse trends, complaints, audit findings, and other manufacturing issues.
- Define technical problems, investigation strategies, hypotheses, and data requirements; apply root-cause analysis, risk assessment, data analysis, and process knowledge to identify and verify potential causes.
- Develop and implement corrective actions, process controls, monitoring plans, and confirmatory studies as required.
- Provide technical support during manufacturing events, process start-ups, and implementation of new or modified processes.
- Support formulation feasibility and manufacturability assessments for custom and catalog products, providing technical recommendations with Formulation Sciences and R&D/Product Development.
- Collaborate with cross-functional teams to support manufacturing success.
- Provide technical support for equipment qualification, process validation, commissioning, equipment modifications, and process implementation.
- Develop and deliver technical training on new or modified processes, equipment, procedures, and controls.
- Support change-control activities through technical assessments, implementation planning, documentation, and effectiveness monitoring.
- Perform other engineering-related duties and responsibilities as assigned.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- 401(k)
- Paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
