Senior MSAT Engineer: Process Transfer & Validation Lead

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

Job summary

FUJIFILM Biotechnologies is seeking an MSAT Engineer 3 to provide technical leadership across cGMP manufacturing, delivering end-to-end support for scale-up, process validation, continued process verification, and continuous improvement. You will drive technology transfer of drug product processes and collaborate with QA, QC, Supply Chain, and Manufacturing.

The role oversees routine operations, deviation investigations, change control, risk assessments, and data-driven performance monitoring to

Qualifications

• Experience with GMP environment is desired.
• Experience with risk management and RCA tools.

Responsibilities

• Conducts lab and pilot plant experiments
• Generates and coordinates execution sampling protocols
• Serves as SME, leading troubleshooting and RCA/CAPA in deviations
• Executes lab and pilot plant work to solve complex manufacturing problems
• Leads technology transfer across unit operations
• Coordinates, plans, and executes manufacturing process validation runs
• Writes and reviews MBRs and 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 manufacturing data management and statistical analysis for process monitoring
• Writes documentation for internal and external use
• Leads training of manufacturing staff and process sciences group
• Interprets and utilizes new knowledge for data-based decisions
• Collaborates with manufacturing to support campaigns
• Leads continuous improvement projects to improve manufacturability
• Supports supplier evaluations and raw material qualification
• Performs other duties as assigned

Skills

GMP experience

Regulatory knowledge

Root cause analysis

Process monitoring

Data-driven decisions

Education

Associate’s degree in Engineering, Life Science or Chemical Engineering

Bachelor’s degree in Engineering, Life Science or Chemical Engineering

Master’s degree in Engineering, Life Science or Chemical Engineering

PhD in related field

Tools

Deviation management system

Change control

CAPA

Document management system

RCA tools

Job description

FUJIFILM Biotechnologies is seeking an MSAT Engineer 3 to provide technical leadership across cGMP manufacturing, delivering end-to-end support for scale-up, process validation, continued process verification, and continuous improvement. You will drive technology transfer of drug product processes and collaborate with QA, QC, Supply Chain, and Manufacturing.

The role oversees routine operations, deviation investigations, change control, risk assessments, and data-driven performance monitoring to