CareDx is Hiring a Senior Process Development Engineer Near Brisbane, CA
CareDx is seeking an independent and highly motivated Senior Process Development Engineer 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, Process Development and Manufacturing to ensure new processes are transferred smoothly.
Responsibilities:
- Lead 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.
- 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 to make critical decisions relating to production operations, using judgment and drawing on external resources as necessary.
- Bachelor's degree or higher in Bioengineering, Industrial Engineering, Mechanical Engineering, Materials Science, Chemical Engineering or related field
- 10 years of process development/manufacturing engineering experience; or Master’s degree with a minimum of 6 years of experience; or equivalent combination of education and experience.
- Extensive industrial experience in the 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.)
- Background in automation, robotics, lab instrumentation and analytical equipment preferred.
- Strong 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.
- 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 a plus.
- Experienced with the systems used in production environments, such as the Laboratory Information Management Systems (LIMS), MES, and business systems.
- Strong project management, project leadership and organizational skills, with great attention to detail. Ability to handle multiple projects at once of varying scope and complexity.
- Excellent interpersonal skills, with demonstrated ability to communicate across disciplines and masterfully summarize and present complex topics, as well as influence others across all levels of the organization.
- Competitive base salary and incentive compensation
- Health and welfare benefits including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
Job Summary
Full Time
Ancillary Healthcare
$100k-117k (estimate)
10/26/2023
05/22/2024
caredx.com
SOUTH SAN FRANCISCO, CA
200 - 500
1998
Public
REGINALD SEETO
$50M - $200M
Ancillary Healthcare
Related Companies
About CareDx
CareDx is a precision medicine company that provides transplant surveillance and pre-transplant HLA typing solutions for transplant patients.
The job skills required for Senior Process Development Engineer include Analysis, Continuous Improvement, Problem Solving, Leadership, Project Management, Troubleshooting, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Process Development Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Process Development Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Process Development Engineer positions, which can be used as a reference in future career path planning. As a Senior Process Development Engineer, it can be promoted into senior positions as a Chemical Process Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Process Development Engineer. You can explore the career advancement for a Senior Process Development Engineer below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
