Process Engineer, MSAT

FUJIFILM Biosciences; Santa Ana (CA); On-site; USD 106,000 - 125,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in Santa Ana, CA, is seeking a Process Engineer, MSAT to develop, scale, transfer, troubleshoot, and improve manufacturing processes for safe and compliant production.

The role leads process studies, test batches, and technical investigations, translating findings into effective process controls and manufacturing solutions to enable reliable, repeatable operations. Strong collaboration across functions is essential.

Qualifications

• B.S. in Chemical Engineering or related discipline.
• 5+ years in process engineering in regulated environments.
• Knowledge of cGMP, FDA regulations, validation, deviations, CAPA.
• Experience in technology transfer, process development, scale-up, and test batches.
• Strong technical writing, communication, and project management.
• English language proficiency.

Responsibilities

• Lead technology transfer and manufacturing implementation.
• Drive process development, scale-up, and test batches.
• Lead or support technical investigations and corrective actions.
• Support formulation feasibility and manufacturability assessments.
• Collaborate with cross-functional teams to enable manufacturing success.
• Provide training on new or modified processes and equipment.
• Assist with change-control activities.

Skills

Process engineering

Technology transfer

Scale-up

Root-cause analysis

Statistical analysis

Cross-functional collaboration

Project management

Documentation

English proficiency

Education

B.S. in Chemical Engineering

Advanced degree preferred

Tools

Microsoft 365

Job description

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

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.
• 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 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

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).