Senior MSAT Engineer: Tech Transfer & Process Excellence

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

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