PROCESS DEVELOPMENT ENGINEER II
Company: CareDx
Location: Brisbane
Posted on: October 19, 2024
Job Description:
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.
The following information aims to provide potential candidates with
a better understanding of the requirements for this role.
Responsibilities:
- Support process 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.
- Lead and/or contribute 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.
- Work 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 a 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.
- 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 leadership a
plus.
- Must have strong attention to detail and ability to handle
multiple projects at once of varying scope and complexity.
- Excellent interpersonal skills, with demonstrated ability 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.
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Keywords: CareDx, Union City , PROCESS DEVELOPMENT ENGINEER II, Engineering , Brisbane, California
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