B.S. in Chemical Engineering or related field; advanced degree preferred.
5+ years of process engineering experience, particularly in manufacturing process development and technology transfer.
Familiarity with cGMP, FDA regulations, and controlled documentation.
Experience in liquid and powder manufacturing in regulated industries is a plus.
Proficient in statistical analysis and process capability assessment.
Strong skills in root-cause analysis and structured problem-solving methodologies.
Excellent technical writing and communication skills.
Responsibilities
Lead technology transfer for new and modified products and processes.
Conduct process development, scale-up, and optimization activities.
Design and execute engineering studies to evaluate process parameters.
Support technical investigations for manufacturing issues and deviations.
Collaborate with cross-functional teams to ensure manufacturing success.
Provide technical training on new processes and equipment.
Develop corrective actions and monitoring plans for process improvements.
Benefits
Medical, Dental, Vision coverage.
Life Insurance.
401k retirement plan.
Paid Time Off.
Full Job Description
Position Overview
We are hiring a Process Engineer, MSAT. 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 and translates technical findings into effective process controls and manufacturing solutions.
Job Description
Responsibilities:
Technology Transfer and Manufacturing Implementation
Lead the cross-functional technology transfer process 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.
Process Development, Scale-Up, and Test Batches
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 to evaluate 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.
Technical Investigations and Manufacturing Support
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.
Formulation and Manufacturability Support
Support formulation feasibility and manufacturability assessments for custom and catalog products.
Evaluate formulation, processing, equipment, and scale-up considerations and provide technical recommendations in collaboration with Formulation Sciences and R&D/Product Development.
Cross-Functional Technical Support
Collaborate with Manufacturing, Formulation Sciences, Packaging Engineering, Quality, Validation, R&D/Product Development, Supply Chain, and the Prototype Laboratory to support manufacturing success.
Provide technical support for equipment qualification, process validation, commissioning, equipment modifications, and process implementation activities.
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.
Other engineering-related duties and responsibilities may be assigned as needed.
Required Skills/Education:
B.S. in Chemical Engineering or a related engineering discipline; advanced degree preferred
5+ years of relevant process engineering experience. Experience in manufacturing process development, characterization, scale-up, technology transfer, or technical investigations is required. Experience in liquid and powder manufacturing and regulated industries is preferred.
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.
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 with proficiency in Microsoft 365 applications.
Ability to speak, read, and write in English.
Good oral and written communication skills.
Salary and Benefits:
For California, the base salary range for this position is $ 106,185.25 - $125,000. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
Medical, Dental, Vision
Life Insurance
401k
Paid Time Off
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About Fujifilm Manufacturing USA, Inc
Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
