Process Development Engineer, Manufacturing Tech & Transfer

Socket.dev; California (MO); On-site; USD 83,000 - 124,000; Full time

Job summary

Illumina is seeking driven Process Engineers for the Manufacturing Technology & Transfer team to develop and deploy reagent formulation, fill and assembly processes for pilot plants and external production. You will partner with Development, Quality, Production, and Supply Chain to transfer and sustain manufacturing processes.

You will contribute to DOE studies, CPM, and advanced quality methods to optimize yield and meet project goals, with emphasis on GMP, cGMP and ISO standards in

Qualifications

• Experience with GMP best practices in production and pilot plants.
• Experience with product development processes and design transfer.
• Experience with SPC and DOE techniques is a plus.
• Experience with cGMP, 21 CFR 820, ISO 13485/14971 in FDA environments.
• Strong communication, analytical and organizational skills.
• Experience with high-volume production in consumables is a plus.
• Experience with product development processes and project management is a plus.
• Ability to work across multiple departments.
• Knowledge of lyophilization and formulation development is desirable.
• Knowledge of liquid handling automation (Hamilton/Tecan) is desirable.

Responsibilities

• Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products to sequence genomes.
• Represent Operations needs on development teams for effective transfer of products into manufacturing.
• Define technical requirements for manufacturing processes and new production equipment.
• Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment.
• Design, develop and source production equipment from vendors and OEMs, work cross functionally with EHS and Facilities to establish safe production processes to enable manufacturing of consumable products.
• Troubleshoot new product and manufacturing process issues related to yield, quality and throughput.
• Provide technical oversight, coordination and execution of development and pilot plant builds within the Pilot Plant production area supporting multiple projects and initiatives.
• Develop understanding of CPM (critical parameter management), construct and execute controlled experiments and including DOE's to optimize processes, address yield and quality issues and drive implementation of solutions into a production environment to meet project goals.
• Analyze process test results, issue reports and make technical recommendations to improve product and process quality.
• Utilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during product and process development phases of new product introductions.
• Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality teams to enable operations for both launch and high-volume manufacturing.
• Ensure successful transfer of knowledge into manufacturing and the sustaining support teams.

Skills

GMP experience

DOE techniques

Six Sigma

Statistical analysis

Cross-functional collaboration

Lyophilization knowledge

Liquid handling automation

Education

B.S./M.S./PhD in Mechanical Engineering, Chemical Engineering, Material Science, or Bioengineering

Tools

Hamilton Robotics

Tecan

Job description

Illumina is seeking driven Process Engineers for the Manufacturing Technology & Transfer team to develop and deploy reagent formulation, fill and assembly processes for pilot plants and external production. You will partner with Development, Quality, Production, and Supply Chain to transfer and sustain manufacturing processes.

You will contribute to DOE studies, CPM, and advanced quality methods to optimize yield and meet project goals, with emphasis on GMP, cGMP and ISO standards in