Engineer 2- Process Development

Illumina San Diego , CA 92140

Posted 2 months ago

We are looking for driven, talented Process Engineers to join our growing Life Cycle Management (LCM) group. The LCM group works as an integral part of our Consumables Development and Manufacturing process and is tasked with increasing quality and yield within our high-volume production environments.

In this role, the individual will use sound and proven engineering principles, best practices, and concepts in order to assist in developing processes and process requirements from internal and external stakeholders. The individual will be an integral member of teams that provide technical leadership to new product introduction, and production process development. Additionally, s/he will partner cross-functionally with R & D, Quality, Production, Supply Chain, and other engineering groups to develop and sustain processes for new products.

Responsibilities:

  • Participate in process development, definition, improvement, and activities related to consumable products manufacturing used to sequence genomes.

  • Troubleshoot new product and process issues related to yield, quality, and throughput.

  • Construct, execute, and report on controlled experiments (including DOE) to optimize processes, address yield/quality issues, and drive implementation of solutions in a GMP production environment to meet project and production goals.

  • Analyze process test results, issue reports, and make technical recommendations.

  • Work cross-functionally with R&D, Manufacturing, and Quality to develop requirements for new processes related to consumable product fabrication for new products

  • Collaborate with manufacturing and quality teams to improve manufacturing processes of existing products.

  • Represent Operations' needs on development teams.

  • Work with suppliers to ensure processes are capable, have controls in place, and can meet delivery requirements.

  • Evaluate suppliers for technical capabilities including equipment design, process controls, automation, and quality control systems.

  • Lead/participate in process/equipment validations, CAPAs, complaint investigations, product and process non-conformances, risk analysis, and supplier surveillance

  • Drive selection and qualification of critical suppliers for devices and high volume manufacturing equipment

  • Create content for manufacturing work instructions

  • Develop requirements, experiments/DOEs, and help with transfer capabilities from one platform to another

Requirements:

  • Work experience in the biotech, pharmaceutical or chemical industries is desirable.

  • Experience with chemical processes and mechanical processes preferred.

  • Experience with Statistical Process Control and DOE techniques is a plus.

  • Experience with high volume manufacturing in a high-tech, high-volume consumables industry is a plus.

  • High level computer skills are required. Programming knowledge is a plus.

  • High-level problem solving and reasoning skills are required.

  • Experience with product development processes and project management is a plus.

  • Good interdepartmental communication skills and documentation skills are required.

  • Demonstrated ability to accomplish goals while working across departments is required.

  • Experience working as a member of a process/product development team, developing high reliability solutions according to specifications and timelines.

  • Experience in evaluating, testing, and implementing process automation in a high volume production setting is desirable.

  • Experience with statistical analysis software (R, JMP, etc) is desirable.

  • Experience working in an ISO13485 or FDA certified environment is a plus.

  • Demonstrate strong written and verbal communication skills, including ability to work with diverse cultures and global partners

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Education:

  • Ph.D. in Mechanical Engineering, Chemical Engineering, Material Science, Bioengineering, or similar discipline
  • B.S./M.S. in Mechanical Engineering, Chemical Engineering, Material Science, Bioengineering, or similar discipline with 1-3+ years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement, and validation.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


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Engineer 2- Process Development

Illumina