Senior Process Engineer

3 days ago


Sanford, United States Kyowa Kirin, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Process Engineer to join our team at Kyowa Kirin, Inc. in Princeton, NJ. As a key member of our manufacturing team, you will be responsible for the design, commissioning, and operation of our manufacturing facility, including technical transfer, process definition, troubleshooting, and process optimization.

Key Responsibilities
  • Provide hands-on support and guidance for the installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility.
  • Take ownership of systems within Upstream Processing, Downstream Processing, or Solution Preparations and maintain a cradle-to-grave accountability for the systems assigned, from design through operations acceptance.
  • Create, review, and approve documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.
  • Participate in the facility's Operational Readiness (OR) planning and execution.
  • Collaborate with manufacturing, manufacturing sciences, and automation to evaluate new product introductions.
  • Assist with preparation of maintenance, calibration, and qualification plans.
  • Manage technical and engineering changes (change control).
  • Support internal and external audits.
Requirements
  • Bachelor's degree qualified in Chemical, Mechanical, or Biotechnology engineering or related field.
  • Minimum 5 years' experience as a process engineer in Pharma, Biopharma, and/or Life Science industries in a manufacturing/operations role.
  • Knowledge and experience of Single Use Technology (SUT), preferably in monoclonal antibody (mAb) processing.
  • Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to both clinical and commercial manufacturing.
  • Experience with starting up and operating a biopharma manufacturing facility is a plus.
What We Offer

We offer a dynamic and inclusive work environment, with opportunities for professional growth and development. Our team is passionate about delivering breakthroughs in the biotech industry, and we are committed to making a positive impact on people's lives.

As a Senior Process Engineer at Kyowa Kirin, Inc., you will have the opportunity to work on challenging projects, collaborate with a talented team, and contribute to the development of innovative solutions. If you are a motivated and experienced process engineer looking for a new challenge, we encourage you to apply for this exciting opportunity.


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