Sr Engineer - Process Development

Illumina•San Diego, CA

22h

About The Position

We are looking for driven, talented Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. This position is an integral part of our Reagent Development team and is tasked with developing and deploying oligonucleotide manufacturing processes. The individual will partner closely with development teams, Quality, Production, Supply Chain, and other engineering groups to develop and transfer sustainable manufacturing processes.

Requirements

Expertise with all oligonucleotide processes (synthesis, cleavage/deprotection, purification, desalting, and in-process and final QC) and equipment (synthesizers, preparative HPLCs, analytical HPLCs, MSs, UV Specs, etc)
Experience with liquid handlers and ERP systems is a plus
Demonstrated ability to accomplish goals while working across departments
Effective communication (both verbal and written) and organizational skills to manage competing project priorities
Expertise with Statistics, Statistical Process Control and DOE techniques
Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred
Experience with high volume production in a high tech consumables industry is a plus
Experience with product development processes and project management is a plus

Responsibilities

Execute feasibility and development oligonucleotide builds as necessary to support various projects timelines
Ideate and create manufacturing processes and define technical requirements for new production equipment
Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
Construct and execute controlled experiments including DOE's to optimize processes and scale; address yield/quality issues and drive implementation of solutions into a production environment to meet project goals
Analyze process test results, author reports and inform technical recommendations to improve product and process quality
Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities teams by representing Oligo MTT on NPI core teams
Ensure successful transfer of knowledge into manufacturing and the sustaining support teams