Sr Engineer - Reagent Process Engineering (PMT Lead)

Company: Illumina
Company: Illumina
Location: US - California - San Diego
Commitment: Full time
Posted on: 2023-12-23 05:12
What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.We are looking for a driven, talented Sr Reagent Process Development Engineer to join our growing Reagents Technical Operations (RTO) team. The RTO group works as an integral part of our Consumables Manufacturing process and is tasked with increasing quality and yield within our high-volume production environments. These individuals provide technical and operations leadership to production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production, Platform Management Team (PMT) and other engineering groups to develop processes for new products, as well as sustain and improve processes for existing products. This individual will be supporting the Reagent Formulation space, helping to stabilize and improve the related processes through troubleshooting, addressing key issue candles, cost-savings projects and SPC.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 Troubleshoot new product and manufacturing process issues related to yield, quality and throughput 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 Requirements: Work experience in the medical device, biotech, pharmaceutical, industries is desired Experience with reagent formulation, filling, Lyophilization processes, labeling and packaging technologies preferred Experience and understanding of complex automated manufacturing systems, tools and components (electrical and pneumatic control, sensors, metrology systems, PLCs) is desired Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred Effective communication skills both verbal and written, analytical and organizational skills to manage competing project priorities Experience with Statistics, Statistical Process Control and DOE techniques is a plus Experience with product development processes, design transfer and process and equipment validation High level problem solving, and reasoning skills required Experience with high volume production in a high tech, high volume consumables industry is a plus • High level computer skills are required. Intermediate level programming knowledge is a plus Experience with product development processes and project management is a plus Demonstrated ability to accomplish goals while working across departments is requiredEducation and Experience B.S./M.S. in Mechanical, Chemical Engineering, Bioengineering, Manufacturing Engineering, or Material Science with at least 8 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation PhD in Mechanical, Chemical Engineering, Bioengineering, Materials Science with at least 3 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation is a plus The estimated base salary range for the Sr Engineer - Reagent Process Engineering (PMT Lead) role based in the United States of America is: $86,500 - $129,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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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