Engineer 3, DPFG MSAT

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks an MSAT Engineer 3 to provide technical leadership across cGMP manufacturing, enabling scale-up, validation, and continued process verification. You will partner with Process Engineering, QA, QC, Supply Chain and Manufacturing to ensure robust transfer of drug product processes and compliant documentation for reliable supply.

The role focuses on on-floor support, investigations, risk assessments, and data-driven performance monitoring, plus

Qualifications

• Degree in engineering, life science, or chemical engineering with relevant industry experience.
• Experience in GMP environments and quality systems.
• Strong knowledge of regulatory standards for sterile products.

Responsibilities

• Conducts lab and pilot plant experiments.
• Generates and coordinates execution sampling protocols.
• Lead and conduct troubleshooting, RCA, and CAPA in response to deviations.
• Executes and analyzes lab and pilot plant work to solve complex manufacturing problems.
• Leads and supports technology transfer across unit operations.
• Coordinates, plans, and executes manufacturing process validation runs.
• Supports design and generates sampling plans for PVRs and investigations.
• Writes and reviews MBRs and SOPs as needed.
• Generates and executes process training and consults on manufacturing topics.
• Leads risk assessments for new processes
• Manages manufacturing data and performs statistical analyses for process monitoring and CPP.
• Writes documentation for internal/external use such as campaign summaries and PPQ protocols.

Skills

Lab experiments

Troubleshooting

Root cause analysis

CAPA

Technology transfer

Process validation

Data analysis

QA collaboration

Documentation writing

Continuous improvement

Education

Associate's degree in Engineering

Bachelor's degree in Engineering

Master’s degree in Engineering

PhD in related field

Job description

Position 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.

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

Job Description

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 experienceOR
• 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

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]).