Process Improvement Engineer

1 week ago


Brisbane, California, United States CareDx, Inc. Full time
Overview

CareDx, a leading biotechnology company, is seeking an experienced Process Improvement Engineer to enhance our CLIA and manufacturing processes. As a key member of our team, you will play a critical role in optimizing our operations to improve efficiency, quality, and patient outcomes.

Salary

$120,000 - $180,000 per annum, depending on experience, plus benefits.

Job Description

We are looking for a skilled Process Improvement Engineer to join our team. Your primary responsibility will be to monitor and improve diverse CLIA and manufacturing processes, ensuring compliance with regulations and industry standards. You will work closely with R&D, Clinical Lab, Quality, Supply Chain, Process Development, and Manufacturing teams to ensure seamless process transfers and equipment validation.

  • You will support process optimization, technology transfer, scale-up, capacity planning, and equipment/process validation activities.
  • Develop and qualify robust, high-quality, and cost-effective processes for production.
  • Responsible for process and equipment validation, including developing protocols, execution, and generating reports.
  • Lead cross-functional teams consisting of Manufacturing, R&D, Quality, Automation Engineering, Informatics, and/or Supply Chain.
  • Drive implementation through operations, including setting up infrastructure, production documentation, and training on new processes and equipment.
Required Skills and Qualifications

To succeed in this role, you will need:

  • Bachelor's degree or higher in Bioengineering, Industrial Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, or related field.
  • 5+ years of process engineering, process development/manufacturing engineering experience; or Master's degree with a minimum of 4 years of experience; or equivalent combination of education and experience.
  • Related industry experience in process improvement, scale-up, transfer, and validation of molecular biology-based lab processes and reagents.
  • Solid analytical skills in statistics, time-series analysis, Pareto analysis, data visualization, etc.
  • Experience working in an CLIA, ISO13485, or cGMP regulated environment, either within the life sciences, medical devices, or biopharmaceutical products highly desirable, with strong working knowledge of Design Control requirements and Quality Systems.
Benefits

CareDx offers a competitive total rewards package, including:

  • Competitive base salary and incentive compensation
  • Health and welfare benefits
  • 401(k) savings plan match
  • Employee Stock Purchase Plan
  • Pre-tax commuter benefits


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