Process Sciences Engineer II

3 days ago

College Station, Texas, United States FUJIFILM Holdings America Corporation Full time
Job Title: Process Sciences Engineer II

Fujifilm Holdings America Corporation is seeking a highly skilled Process Sciences Engineer II to join our team. As a key member of our manufacturing group, you will be responsible for analyzing process technologies and assisting in the technical transfer of biological drug processes from development to manufacturing.

Key Responsibilities:
  • Apply scientific and cGMP manufacturing expertise to address complex issues in technology transfer and implementation of client specified manufacturing processes for biologics.
  • Lead cross-functional technology transfer teams to ensure seamless execution of client projects.
  • Identify and procure single-use process equipment of appropriate scale and quality for cGMP execution of client specified manufacturing processes.
  • Prepare user requirements, obtain vendor quotes, and capital requests for equipment.
  • Provide technical information for change controls, protocols, and new user training for process equipment.
  • Review process specifications and provide input for scale up and requirements for GMP manufacturing.
  • Review batch records prepared based on process specification.
  • Identify raw materials and consumables of appropriate quality for cGMP execution of client specified manufacturing processes.
  • Respond to client and internal staff questions or concerns about cGMP equipment, materials, and procedures.
  • Use key and critical process parameters and their associated critical quality attributes in product specifications.
  • Provide data analysis from each manufacturing run for intermediate and final project summary reports.
Requirements:
  • PhD, Master's Degree with 4 years of relevant experience, or Bachelor's Degree with 6 years of relevant experience.
  • Experience in a cGMP environment, preferably in biologics and vaccine manufacturing.
  • Hands-on process development or manufacturing experience with clinical scale projects.
  • Documented understanding and experience in aseptic techniques.
  • Document writing skills, including protocols, batch records, and SOPs.
  • Experience with Microsoft Excel, Word, and PowerPoint, and materials management with SAP.
Preferred Qualifications:
  • Degree in Engineering, Chemistry, Biology, Life Sciences, or related field.

Fujifilm Holdings America Corporation is an equal opportunity and affirmative action employer. We are committed to diversity and inclusion in the workplace. If you are a motivated and experienced professional looking for a challenging role, please submit your application.

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