Process Engineer, MSAT

Fujifilm; Santa Ana (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Biosciences seeks a Process Engineer, MSAT to develop, scale, transfer, troubleshoot, and improve manufacturing processes supporting safe and compliant production. You will lead studies, test batches, and investigations, translating findings into process controls and manufacturing solutions.

The role emphasizes cross-functional collaboration, transfer documentation, and continuous improvement within a dynamic Biotech environment in Santa Ana, CA and beyond.

Qualifications

• B.S. in Chemical Engineering or a related engineering discipline is required.
• Advanced degree preferred.

Responsibilities

• Lead process transfer and technology transfer for new and modified products.
• Drive process development, scale-up, and test batches to ensure manufacturability.
• Investigate deviations, implement corrective actions, and support manufacturing events.
• Collaborate with cross-functional teams to ensure process controls and documentation.

Education

B.S. in Chemical Engineering or a related engineering discipline

Advanced degree preferred

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.

Company Overview

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world's biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you're ready to make an impact, your future belongs with us at FUJIFILM Biosciences.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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