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Illumina · 1 day ago

Engineer 2 - Process Development • Manufacturing Technology & Transfer Dept

San Diego, CA

Full-time

Onsite

Entry, Mid Level

$82K/yr - $124K/yr

2+ years exp

Illumina is a company focused on expanding access to genomic technology to improve health equity worldwide. They are seeking a Process Engineer to join their Manufacturing Technology & Transfer team, responsible for developing and deploying reagent formulation and assembly processes, and providing technical leadership for new product introductions.

BiotechnologyGeneticsHealth CareMedical

No H1B

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 OEM’s, 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

Qualification

Process developmentGMP best practicesStatistical Process ControlCGMP knowledgeLyophilization developmentLiquid handling automationProject managementAnalytical skillsEffective communicationOrganizational skills

Required

Work experience in production, pilot plant, and/or process development following GMP best work practices and techniques is required

Experience with product development processes, design transfer and process and equipment validation

High level problem solving, and reasoning skills required

Effective communication skills both verbal and written, analytical and organizational skills to manage competing project priorities

Demonstrated ability to accomplish goals while working across departments is required

B.S./M.S./PhD in Mechanical Engineering, Chemical Engineering, Material Science, or Bioengineering, with 2-4 years of relevant experience in process development, scale-up, process improvement, quality engineering

Preferred

Experience with Statistics, Statistical Process Control and DOE techniques is a plus

Experience with cGMP, 21CFR820, ISO 13485 and ISO 14971 supporting manufacturing in an FDA regulated environment is preferred

Experience with high volume production in a high tech, high volume consumables industry is a plus

Experience with product development processes and project management is a plus

Knowledge of or experience with lyophilization cycle development, excipient and formulation development, lyophilization manufacturing sustaining and/or support is highly desirable

Knowledge of or experience with liquid handling and automation such as Hamilton Robotics or Tecan and/or support of processes is highly desirable