Engineer 3, DPFG MSAT

NCBiotech; Holly Springs (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Engineer 3, DPFG MSAT to provide technical leadership in cGMP manufacturing, scale-up, process validation, and continuous improvement. You will drive technology transfer, support on-floor operations, deviations, CAPAs, and data-driven decisions across QA/QC, Supply Chain, and Manufacturing.

You will collaborate with Process Engineering and other groups to ensure robust processes, compliant documentation, and readiness for campaigns and

Responsibilities

• Conducts lab and pilot plant experiments
• Generates and coordinates sampling protocols
• Serves as SME, leading troubleshooting and RCA/CAPA in response to deviations
• Executes and analyzes lab and pilot plant work to solve manufacturing problems
• Leads TT across multiple unit operations
• Coordinates, plans, and executes process validation runs
• Supports design and generation of sampling plans for PVRs/investigations
• Writes and reviews MBRs and SOPs as needed
• Generates and executes process training for staff
• Leads technical risk assessments for new processes
• Manages manufacturing data and performs statistical analysis
• Writes documentation for internal/external use such as PPQ reports
• Leads training of staff on new processes and equipment
• Interprets new knowledge to drive data-based decisions
• Collaborates with manufacturing to support campaigns
• Leads continuous improvement projects in unit operations

Job description

Engineer 3, DPFG MSAT

Job Locations US-NC-Holly Springs

Company (Portal Searching) FUJIFILM Biotechnologies

Company Overview

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

We are 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 are proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Lets 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 Youll 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,