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
We are looking for driven, motivated & innovative New Product Introduction Process Engineers to join our growing Life Cycle Management (LCM) team to support new process development and improvements in high volume manufacturing environment. The NPI Process Engineer will work with cross functional departments such as R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing products.
Position Responsibilities
- Participate in consumables reagent new products introduction and technology transfers for Array and Sequencing products and processes.
- Participate in process definition, improvement, design, development and quality test activities for development and subsequently scaling up and optimizing new products to production.
- Define and develop technical requirements and procedures for manufacturing to process products.
- Construct and execute controlled experiments to address yield and quality issues and drives implementation of solutions in product development process for pilot and scale up.
- Participate in complex technical issues to establish improvement solutions to correct or prevent recurrence of product and process failure.
- Troubleshoot process development, product transfer issues related to yield, quality, and throughput.
- Support development of key strategic process development program, complete design and projects within schedule, budget and quality constraints.
- Present results and data to collaborators, extended teams on a regular basis and senior management when needs.
- Manage and strategize change controls and assessments according to cGMP requirements.
- Manage non-conformances, deviations and root cause analyses according to cGMP requirements.
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
- Bachelor of Science/ Engineering or equivalent in Chemical, Biochemical, Pharmaceutical, Material Science, Chemistry, Biochemistry, Analytical Chemistry and/or Bio-related field.
- High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment
- Experience in process or product development and project management is required.
- Work experience in the biotech/pharmaceutical industries is desirable.
- Excellent organizational skills and attention to detail required.
- Demonstrated ability to work independently.
- Ability to effectively troubleshoot and propose next steps.
- Able to apply Statistical Process Control knowledge and DOE techniques.
- Able to analyze data and make logical and rational conclusions.
- Excellent verbal/written 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 Bachelor’s Degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work 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.
