CareDx is seeking an independent and highly motivated Process Development Engineer II to monitor and improve a diverse collection of CLIA and manufacturing processes. These include the processing of patient samples through various workflows in a CLIA-certified laboratory to Formulation, QC and Filling processes in Reagent Manufacturing. The successful candidate will understand the criticality of each step of the process and closely monitor the key performance indicators that can improve the critical outgoing metrics. They will work closely with R&D, the Clinical Lab, Quality, Supply Chain, Process Development and Manufacturing to ensure new processes are transferred smoothly.
Responsibilities:
- Supportprocess optimization, technology transfer, scale-up, capacity planning, and equipment/process validation activities, as related to either Clinical Lab processes and/or Reagent Manufacturing.Will help to develop and qualify robust, high quality, and cost-effective processes for production.Hands-on participation for execution or training of new personnel, may be required.Opportunities to lead projects available as needed.
- Responsible for process and equipment validation, including developing protocols, execution, and generating reports.
- Will be responsible for leading and/or contributing in cross-functional teams consisting of Manufacturing, R&D, Quality, Automation Engineering, Informatics and/or Supply Chain. Perform project management functions to effectively drive results, manage project schedules, and communicate project status, experimental plans and results. Position may require interaction with other global manufacturing sites, vendors or external partners.
- Drive implementation through operations, including setting up infrastructure, production documentation, and training on new processes and equipment.
- Ensure manufacturability of operations as it pertains to the utilization of staffing, facility (layout, etc.), materials, and equipment.
- Work with R&D and Automation Engineers to establish equipment/instrumentation requirements and specifications. Interfaces with vendors on procurement, installation, maintenance, etc.
- Active monitoring of operations through statistical based review of key metrics, including equipment status, assay performance and QC results. Track customer complaints and respond as necessary.
- Responsible for ongoing technical support of sustaining operations, including troubleshooting of equipment and process problems.
- Generate various documentation such as process flow diagrams, operating procedures, work instructions, equipment SOP’s, validation plans, reports and protocols.
- Conform to requirements for Design Control. Perform design and process risk assessments, such as pFMEA. May conduct design reviews.
- Apply working knowledge of Lean/Six Sigma principles in operations, utilizing various tools (VSM, 6S, Kaizen, Visual Controls, etc.) to drive Continuous Improvement efforts.View processes with an engineering mindset to look at process flow improvements, bottleneck analysis, batch size optimization and efficiency. Develop metrics and controls to drive improvements in the areas of COGS, quality, yield, safety/ergonomics, and TAT.
- Works independently and collaboratively to make critical decisions relating to production operations, using judgment and drawing on external resources as necessary.
Requirements:
- 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. Familiarity with the formulation, handling and processing of oligo and enzyme-based reagents and principles of biological processes (PCR, sequencing, etc.) a plus.
- Background in automation, robotics, lab instrumentation and analytical equipment preferred.
- Solid analytical skills in statistics, time-series analysis, Pareto analysis, data visualization, etc.
- Experience working in anCLIA, 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.
- Creative thinker, with strong problem-solving skills and ability to think outside of the box.
- Experience in the optimization of production processes through the use of Lean/Six Sigma tools and principles, with strong understanding of Operational Excellence concepts.
- Experienced with the systems used in production environments, such as the Laboratory Information Management Systems (LIMS), MES, and business systems.
- Experience in project management and project leadershipa plus.
- Must have strong attention to detail and ability to handle multiple projects at once of varying scope and complexity.
- Excellent interpersonal skills, with demonstratedability to communicate across disciplines, summarize and present complex topics, as well as influence others across all levels of the organization.
CareDx, Inc. is an Equal Opportunity Employer. #LI-Onsite
