MSAT Process Engineer: Tech Transfer & Scale-Up

FUJIFILM Biosciences

Santa Ana (CA)

Presencial

USD 106.000 - 125.000

Jornada completa

hace 8 horas
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Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision
Life Insurance
401k
Paid Time Off

Descripción de la vacante

FUJIFILM Biosciences in Santa Ana, CA, is seeking a Process Engineer, MSAT to develop, scale, transfer, troubleshoot, and improve manufacturing processes for safe and compliant production.

The role leads process studies, test batches, and technical investigations, translating findings into effective process controls and manufacturing solutions to enable reliable, repeatable operations. Strong collaboration across functions is essential.

Formación

  • B.S. in Chemical Engineering or related discipline.
  • 5+ years in process engineering in regulated environments.
  • Knowledge of cGMP, FDA regulations, validation, deviations, CAPA.
  • Experience in technology transfer, process development, scale-up, and test batches.
  • Strong technical writing, communication, and project management.
  • English language proficiency.

Responsabilidades

  • Lead technology transfer and manufacturing implementation.
  • Drive process development, scale-up, and test batches.
  • Lead or support technical investigations and corrective actions.
  • Support formulation feasibility and manufacturability assessments.
  • Collaborate with cross-functional teams to enable manufacturing success.
  • Provide training on new or modified processes and equipment.
  • Assist with change-control activities.

Conocimientos

Process engineering
Technology transfer
Scale-up
Root-cause analysis
Statistical analysis
Cross-functional collaboration
Project management
Documentation
English proficiency

Educación

B.S. in Chemical Engineering
Advanced degree preferred

Herramientas

Microsoft 365

Descripción del empleo

FUJIFILM Biosciences in Santa Ana, CA, is seeking a Process Engineer, MSAT to develop, scale, transfer, troubleshoot, and improve manufacturing processes for safe and compliant production.

The role leads process studies, test batches, and technical investigations, translating findings into effective process controls and manufacturing solutions to enable reliable, repeatable operations. Strong collaboration across functions is essential.

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