Illumina Inc

San Diego , CA
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Engineer 2, Process Development

Illumina Inc
San Diego, CA Full-time
Posted on September 26, 2019

This individual will provide technical leadership to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.

Responsibilities:

  • Participate in process development, definition and improvement, and other activities in the making of consumable products or support of processes/equipment used to sequence genomes.
  • Work in cross-functional teams to both (1) represent operational needs and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products in production.
  • Construct and execute controlled experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes.
  • Develop assessments and strategies for identifying, managing, and reducing product / process risk utilizing a variety of techniques including FMEAs, DOEs, and Control Plans.
  • Manage process capability in respect to the overall needs of the end sequencing product(s), driving a solutions based approach to address yield and quality issues in a regulated production environment.
  • Troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem solving techniques and quality assurance mechanisms when appropriate (e.g. 8D, A3, and CAPA)
  • Analyze process test results, issue reports and make technical recommendations.
  • Manage small to medium size projects for process improvements and technology transfers
  • Develop technical summaries and provide assistance for regulatory filings
  • Author technical documents including batch records, SOPs, engineering / development reports, and risk / validation assessments.
  • Act as a subject matter expert, mentoring less experienced members of the team and providing training / guidance to manufacturing staff and other members of the organization

Requirements:

  • Work experience in the biotech, pharmaceutical or semiconductor industries is desirable
  • Experience working in an ISO13485 or FDA certified environment is desirable.
  • Experience in high-volume production in a high-tech consumables industry is a plus.
  • High level computer skills are required. Intermediate level programming knowledge is a plus.
  • Experience with chromatographic processes (e.g. IEX, RP, HIC, and SEC) is a plus.
  • Experience with Process Validation and Quality by Design (QbD) experience is a plus
  • Experience in production support and/or process development is required.
  • Experience with statistics, Statistical Process Control and DOE techniques is required.
  • Experience developing risk management and process control strategies is required.
  • High level problem solving and reasoning skills are required.
  • Experience with product development processes and project management skills is required.
  • Demonstrated ability to accomplish goals while working across departments is required.
  • Good interdepartmental communication skills and documentation skills are required.

Education:

  • MS/PhD in Organic Chemistry, Analytical Chemistry, or B.S./M.S./ PhD in Chemical Engineering, Biochemical Engineering with at least 4 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.
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