MSAT Engineer III: Process Transfer & Validation Lead

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an MSAT Engineer 3 to provide technical leadership across cGMP manufacturing, drive technology transfer, and ensure robust processes and compliant documentation.

You will partner with Process Engineering, QA/QC, Supply Chain, and Manufacturing to support scale-up, validation, on-floor support, and continuous improvement, while leading investigations and risk assessments.

Qualifications

• 7+ years of applicable industry experience in engineering, life sciences, or chemical engineering.
• Bachelor's degree in Engineering, Life Science or Chemical Engineering with 5 years of experience.
• Master's degree with 3 years of experience.
• PhD with no prior experience.

Responsibilities

• Conducts lab and pilot plant experiments.
• Generates and coordinates execution sampling protocols.
• Serves as SME, leading troubleshooting, processing impact assessments, and RCA/CAPA in response to deviations.
• Executes and analyzes lab and pilot plant work to solve complex manufacturing problems.
• Leads and supports technology transfer across multiple unit operations.
• Coordinates, plans, and executes manufacturing process validation runs.
• Supports design and leads generation of 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 technical risk assessments for new processes.
• Manages manufacturing data and statistical analysis for process monitoring and CPV.
• Writes documentation for internal/external use like campaign summaries and PPQ reports.
• Leads training of manufacturing staff and process sciences on new processes and equipment.
• Interprets new knowledge to drive data-based decisions.
• Collaborates with manufacturing to support campaigns, including on-floor support.
• Leads continuous improvement projects to improve manufacturability, reliability, yield and cost.
• Supports supplier evaluations, risk assessments, and material qualification.
• Performs other duties as assigned.

Skills

Quality systems usage

Technology transfer leadership

GMP manufacturing knowledge

Process validation

Education

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

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

Master's degree

PhD

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an MSAT Engineer 3 to provide technical leadership across cGMP manufacturing, drive technology transfer, and ensure robust processes and compliant documentation.

You will partner with Process Engineering, QA/QC, Supply Chain, and Manufacturing to support scale-up, validation, on-floor support, and continuous improvement, while leading investigations and risk assessments.