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.Basic Function and Scope of the Position:Provide technical and operational support to the process development/ improvements/ sustaining efforts in a high volume, multi-product manufacturing environment.Works with various functions to develop processes for new products and sustain/ improve processes for existing products.Tasks and Responsibilities:Operational SupportParticipate in process sustaining, definition, improvement, design, development and quality testing activities in conjunction with Manufacturing, Validation, Supply Chain, Quality Assurance, Facility and Regulatory Affairs. Improve process capability, production efficiency and capacity while maintaining and improving quality standards.Troubleshoot, performing root cause analysis and provide optimized data-driven solutions for line issues related to yield, quality and throughput in a multi-product manufacturing facility.Participate in establishing operating equipment specifications and improvements.Analyze process test results, issue reports and makes technical recommendations. Construct and execute controlled experiments to address yield and quality is‐sues and drives implementation of solutions in a production environment to meet production goals. Serve as a peer-recognized subject matter expertise in at least one area.Design EngineeringWork cross functionally with R&D, Manufacturing and Quality to develop cost effective and working production processes for new products and improve processes of existing products.Define technical requirements and procedures for manufacturing to process product.Evaluate raw material, formulation recipe and process changes, plan and execute associated qualification activities.Compliance/TrainingEnsure system and process equipment comply with corporate quality system and regulatory requirements.Execute training plan across functions.LeadershipLead or support development of key strategic program, complete design and engineering projects within schedule, budget and quality constraints.Provides guidance to junior engineers.All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Preferred Educational Background:Bachelor of Science/ Bachelor of Engineering/ Masters or equivalent in Chemical, Biochemical, Biochemistry and/or Bio-technology related field.Preferred Experiential Background:2- 5 years’ of relevant experience required.Work experience in the biotech industries is strongly preferred.Experience in a high-tech, high-volume, high-mix consumables manufacturing industry.Possess cGMP knowledge. Experience in FDA-regulated environment is a plus.Proficiency with chemical processes and analysis.Expertise in raw material evaluation, chemical and biological.Strong project management skills.Excellent organizational skills and attention to detail. Competencies:Manage and/ or facilitate change.Good inter-departmental communication skills.Good documentation skills and ability to write procedures and training manual.Demonstrated ability to work independently.Basic troubleshooting skills using computer software.Able to apply DOE techniques and Statistical Process Control knowledge.Able to analyze data and make logical and rational conclusion.Able to perform simple lab work dealing with common chemicals.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.
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