MSAT Engineer: Tech Transfer & Process Optimization

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

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