Process Engineer, MSAT

Fujifilm•Santa Ana, CA

4d•Onsite

About The Position

The MSAT Process Engineer develops, scales, transfers, troubleshoots, and improves manufacturing processes to support safe, compliant, reliable, and repeatable production. The role leads process studies, test batches, and technical investigations, then translates findings into effective process controls and manufacturing solutions. The engineer leads technology transfers for new and modified products and processes, assessing readiness, risks, technical gaps, site requirements, deliverables, and acceptance criteria. The role supports knowledge transfer, manufacturing execution, issue resolution, and transition to routine production, and prepares or reviews transfer documentation and technical records. The position also leads process development, characterization, scale-up, optimization, and manufacturing-readiness activities. It designs and executes engineering studies and test batches, applies engineering and statistical methods to assess process capability and variability, and turns results into controls, specifications, operating ranges, implementation plans, and risk mitigations. The engineer leads or supports manufacturing investigations and provides technical support during manufacturing events and process start-ups. The role supports formulation feasibility and manufacturability assessments and collaborates with cross-functional teams on equipment qualification, validation, commissioning, equipment modifications, process implementation, training, and change control. Other engineering-related duties may be assigned as needed.

Requirements

B.S. in Chemical Engineering or a related engineering discipline.
At least 5 years of relevant process engineering experience.
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 in Microsoft 365 applications.
Ability to speak, read, and write in English; good oral and written communication skills.

Nice To Haves

An advanced degree.
Experience in liquid and powder manufacturing.
Experience in regulated industries.

Responsibilities

Lead cross-functional technology transfers for new and modified products and manufacturing processes; assess 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 for new and existing products.
Define study objectives, hypotheses, risks, success criteria, and data requirements; design and execute engineering studies and test batches.
Evaluate process parameters, material interactions, equipment effects, operating ranges, and controls using engineering and statistical methods.
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.
Use root-cause analysis, risk assessment, data analysis, and process knowledge to identify and verify potential causes; develop corrective actions, process controls, monitoring plans, and confirmatory studies as needed.
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, evaluating formulation, processing, equipment, and scale-up considerations with Formulation Sciences and R&D/Product Development.
Collaborate with Manufacturing, Formulation Sciences, Packaging Engineering, Quality, Validation, R&D/Product Development, Supply Chain, and the Prototype Laboratory.
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.