Engineer 3, DPFG MSAT

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

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.

Job Description

What You’ll 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, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
• Performs other duties, as assigned

Minimum Requirements

• Associate’s degree in Engineering, Life Science or Chemical Engineering with 7 years of applicable industry experience OR
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 5 years of applicable industry experience OR
• Master’s degree with 3 years of applicable industry experience OR
• PhD with no prior experience
• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
• Experience using risk management and RCA tools

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment
• Strong knowledge of regulatory standards and guidance documents for sterile medicinal products
• Prior Drug Product and manufacturing experience, including process development, validation, and transfer
• Experience with drug product formulation, sterile filtration including filter validation, isolator filling equipment, single-use systems, qualifying visual inspection including manual and automated, and validating CCIT methods

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).