Process Engineer

5 days ago


Bothell, Washington, United States Omni Inclusive Full time
Job Title:

Process Engineer

Job Summary:

We are seeking a highly skilled Process Engineer to support the implementation of cell therapy manufacturing technologies and process changes related to the technical transfer of a clinical CAR T Therapy at our Cell Therapy Manufacturing Plant in Bothell, WA.

Key Responsibilities:
  • Support the Sr. Manager in establishing the requirements for the manufacturing process, coordinating technical transfers to manufacturing and between sites, and developing process qualification and process documentation.
  • Develop process control and comparability strategies, and contribute to the overall CMC and technical transfer/commercial strategy.
  • Work closely with Quality Assurance, global MSAT, Manufacturing, Supply Chain, and Project Management organizations to ensure quality and compliance.
  • Manage quality records, stakeholder relationships, and technical documentation.
  • Collaborate with cross-functional teams to identify opportunities for process improvements and operational efficiencies.
Requirements:
  • Bachelor's Degree in life sciences/engineering or equivalent.
  • 0-3 years of relevant experience, preferably in the cell therapy industry and/or tech transfer/LCM.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a fast-paced matrix environment.
  • Detail-oriented with strong analytical and problem-solving skills.
Working Conditions:

This position will be based in Bothell, WA, and will require occasional travel to other sites. The working conditions are normal office environments, with occasional work in the GMP controlled cleanroom.


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