Staff Process Engineer, Operations

CS Genetics

Single-cell at Scale | Single-cell at Speed

Staff Process Engineer, Operations, San Diego, CA
About CS Genetics
CS Genetics is a privately held genomics-technology company based in San Diego, California and Cambridge, UK. We are a nimble, highly capable team focused on delivering genuine step-change innovation in genomic tools for research and clinical applications. We have developed a disruptive platform for single-cell genomics which leverages instrument-free, solution-phase chemical biology to provide unmatched ease-of-use, scalability, and affordability.
Position Summary
The Staff Process Engineer will partner deeply with R&D to drive process development and overall design transfer for a new, cutting-edge single-cell genomics product line.  Responsibilities will include emersion into and mastery of the core technology to enable manufacturing process development for operations spanning formulation, filling, and finish along with associated documentation, and contributing to pilot and production manufacturing qualification, and QC development activities as required to support commercial milestones.  The candidate will also lead efforts to develop methods to use internal and external data and input to identify critical attributes of key manufacturing processes to improve the quality and cost of manufacturing workflows.  When issues occur, the candidate will conduct root cause analysis of failure modes and implement corrective actions as necessary.
Key Responsibilities
·       Oversee technical knowledge transfer from R&D to Operations
·       Evaluates existing R&D scale production and develops Manufacturing scale processes
·       Builds and gathers cross functional approval for transfer packages from R&D to Manufacturing for initial product rollouts and periodic revisions
·       Provides pre- and post-production support and troubleshooting of manufacturing issues
·       Collaborate with R&D to develop and characterize reagent formulation processes to support initial scaling requirements based on commercial forecast
·       Participate in labeling and packaging design
·       Document all manufacturing processes and create product documentation including drawings, bill of materials, routings, and specifications
·       Analyze and trend process and performance data, design and when appropriate execute experiment and studies to improve the manufacturing processes
·       Work closely with R&D, Manufacturing, and Customer Support in the resolution of manufacturing non-conformances and customer reported issues
·       Develop relevant data tracking and trending approaches to monitor processes and discover other areas for improvement
·       Collaborate with Supply Chain in defining and ensuring vendors meet material specification
·       Participate in equipment and material selection to meet product design and scalability goals
·       Present technical data in cross-functional meetings
·       Additional duties as required
Minimum Requirements/Qualifications
·       B.S with 10+ years or M.S. with 8+ years of experience in Biotechnology, Chemical, Industrial, Electrical or Mechanical Engineering or related area in the life sciences and genomics is highly preferred
·       Preferred educational background in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biochemistry, or other related majors
·       Extensive knowledge of statistical analysis, data visualization, and design of experiments (DOE) tools and applications
·       Experience in statistical software and databases (e.g., JMP)
·       Ability to present complex data using effective communication methods and styles, including good technical report writing skills
·       Understands principles of design for manufacturing
·       Knowledgeable in life sciences manufacturing and requirements products used in genomics library preparation
·       Hands-on experience in quality and process engineering in large scale manufacturing environments
·       Experience in lean manufacturing and continuous improvement methodologies, such as Six Sigma is preferred
·       Understanding of product costing, yield, quality, and productivity metrics
·       Experience working with contract manufacturing partners is preferred
·       Experience in a ISO 13485 Manufacturing environme­­­nt preferred
·       Experience in supporting implementations of MES, ERP & PLM
What We Offer
·       Exceptional team with a dynamic and interactive culture
·       Opportunity to work side-by-side with key leadership to build operations capability from the ground up
·       Regular company and community social activities
·       Competitive compensation package including equity incentive program
·       Visa sponsorship available for exceptional candidates

Tagged as: DOE, engineering, process development

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