Engineer 3, DPFG MSAT

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll 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:

Associates degree in Engineering Life Science or Chemical Engineering with 7 years of applicable industry experience OR
Bachelors degree in Engineering Life Science or Chemical Engineering with 5 years of applicable industry experience OR
Masters 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 committedto 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 ().

Required Experience:

Position OverviewThe 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...