Staff Engineer, Product Lifecycle

3 Months ago • 3-8 Years • Product Management

Job Summary

Job Description

The Staff Engineer, Product Lifecycle will lead process development, improvements, and sustaining efforts in a high-volume, multi-product manufacturing environment. This includes conducting experiments, scaling up processes, transferring technology, and supporting cGMP for new product launches. The role involves collaborating with various departments like R&D, manufacturing, and quality, and requires a strong understanding of process definition, improvement, and design. The engineer will also lead technology transfer and serve as a subject matter expert. The role will mentor a team, and requires strong program and project management skills, experience in biotech industries, proficiency in optics and imaging, knowledge of cGMP, and the ability to work in a fast-paced environment.
Must have:
  • Strong program and project management skills.
  • Experience in the biotech industries is preferred.
  • Proficiency in optics and imaging, chemical processes and analyses.
  • Possess cGMP knowledge.
  • Experience in a high-tech, high-volume consumables manufacturing industry.
  • Excellent organizational skills and attention to detail.

Job Details

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. Position Summary: Key leader within a group responsible for performing process development, improvements and sustaining effort in a high volume, multi-product manufacturing environment. This includes timely completion of small-scale experiments, scale-up, technology transfer, cGMP support for programs that bring new products to commercial manufacturing phases, troubleshooting problems, analyzing data and issuing reports. Collaborate and communicate within the framework of cross-functional and multi-disciplinary process development. The individual will interact extensively with other departments such as research and development, manufacturing, facilities, supply chain, project management and quality to develop processes for new products and sustain and improve processes for existing products. Position Responsibilities:
  • Key leader in process definition, improvement, design, development, sustaining and quality test activities in conjunction with Manufacturing, Validation, Supply Chain, Quality Assurance, Facility and Regulatory Affairs. 
  • Design, execute and lead experiments for optimization and process robustness studies. Leads experimentation and manufacturing support to address complex yield and quality issues and drives implementation of solutions in manufacturing environment to meet quality and production goals.
  • Leads technology transfer of multiple programs spanning all phases of product lifecycle, including design, development, pilot run, scale up and oversight of cGMP, engineering and commercial manufacturing.
  • Serves as a peer-recognized subject matter expertise.
  • Organizational support and cross-functional project team leadership and participation. Advises management on goals and project direction.
  • Effectively leads, trains and mentor group.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Position Requirements: Skillsets
  • Strong program and project management skills.
  • Work experience in the biotech industries is strongly preferred.
  • Proficiency in optics and imaging, chemical processes and analyses.
  • Possess cGMP knowledge. Experience in FDA-regulated environment is a plus.
  • Experience in a high-tech, high-volume consumables manufacturing industry.
  •  Excellent organizational skills and attention to detail required.
  • Competent in programming language to perform data query, building data analysis tool and simulation model
Competencies
  • Ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program and product quality/availability timelines.
  • Excellent problem-solving abilities.
  • Thorough knowledge of advanced scientific theories, principles, concepts, experimental techniques, industry practices and standards.
  • Proven record of technical leadership, ability to motivate and influence technical rigor.
  • Dealing with and managing change.
  • Extensive project leadership experience to drive the planning and management of risks, priorities and contingencies.
  • Good inter-departmental communication skills.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Preferred Experience/Education/Skills: Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years’ experience; or equivalent experience. 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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About The Company

At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic.



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