Engineer 3, DPFG MSAT

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive - what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

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

Overview

The Manufacturing Science and Technology (MSAT) Engineer 3 provides technical leadership across current good manufacturing practice (cGMP) manufacturing, delivering end-to-end support for scale-up, process validation, continued process verification, and continuous improvement. This role drives technology transfer (TT) of new and existing drug product processes into and between sites, ensuring robust process fit, compliant documentation, and readiness through close collaboration with Process Engineering, Quality Assurance (QA), Quality Control (QC), Supply Chain, and Manufacturing. The Engineer 3, MSAT DPFG provides technical oversight for routine manufacturing operations, including on-floor support, deviation and root-cause investigations, change control, risk assessments, and data-driven performance monitoring, ensuring product quality, compliance, and reliable supply.

External US

What You'll Do:

Conducts lab and pilot plant experiments

Generates and coordinates execution sampling protocols

Serves as subject matter expert (SME), leading and conducting troubleshooting, processing impact assessments, and executing root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations

Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems

Leads and supports technology transfer (TT) across multiple unit operations

Coordinates, plans, and executes manufacturing process validation runs

Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations

Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed

Generates and executes process training and consults on topics related to manufacturing and process

Leads technical risk assessments for new manufacturing processes

Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification

Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.

Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab

Interprets and utilizes new knowledge to promptly drive data-based decisions

Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support

Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost

Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification

Performs other duties, as assigned

Minimum Requirements:

Associate’s degree in Engineering, Life Science or Chemical Engineering with 7 years of applicable industry experience OR

Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 5 years of applicable industry experience OR

Master’s degree with 3 years of applicable industry experience

OR

PhD with no prior experience

Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)

Experience using risk management and RCA tools

Preferred Requirements:

Experience working in a Good Manufacturing Practices (GMP) environment

Strong knowledge of regulatory standards and guidance documents for sterile medicinal products

Prior Drug Product and manufacturing experience, including process development, validation, and transfer

Experience with drug product formulation, sterile filtration including filter validation, isolator filling equipment, single-use systems, qualifying visual inspection including manual and automated, and validating CCIT methods

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 (FDBN_PNC@fujifilm.com).