San Jose, California

MSAT Process Engineer II
San Jose, CA

Your Tasks:

As a member of the team, you will lead the technology transfer of small to medium scope clinical cell therapy projects for internal and external clients. Additionally, you will serve as a process owner and drive Continuous Improvement projects and Business Process Improvement activities of a medium scope. As a result of your ability to review, approve and/or author GMP documentation, protocols and reports, you will support the continued success of the company as a whole.

Among other responsibilities, you will:

  • Troubleshoot processing issues, including investigation for root cause and implementation of corrective and preventive action (CAPA) plans.
  • Lead risk assessments, root cause analysis and similar activities.
  • Participate in research and development activities.
  • Mentor junior employees.

Requirements:

  • Bachelor's or Master's degree from a four year college or university in biological or biomedical discipline, or related scientific discipline, minimum of 5-8 years progressive experience in clinical processing in the cell therapy industry and/or cell culture operations in the biotechnology industry; or equivalent combination of education and experience.
  • Advanced understanding of cGMP and regulations/guidance.
  • Advanced Understanding of Prodigy and aseptic processing
  • Interpret guidance documents and make technical recommendations.
  • Strong technical writing and communication skills.
  • Advanced understanding of statistical methods.
  • Expert understanding in product lifecycle.
  • Advanced understanding of technology transfer, qualification, and validation

For immediate consideration apply today!

Questions? Please reach out to Dustin at DUSG877@kellyservices.com

#TJP2021_SPEC



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San Jose, California

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