Senior Process Development Engineer | Illumina

As an Illumina Process Development Engineer, you will be responsible for new product introduction, process development and transfer to Operations library preparation, sequencing, and micro-array assay products. This role will ensure best-in-class product quality and optimized cost of goods through proactive integration of risk-based design requirements, performance testing controls, and manufacturing strategies into the product development process.

Responsibilities:

  • Establish process requirements to meet product specifications.

  • Lead and guide the construct and execution of controlled experiments (including DOEs, gauge R&R studies, process scale up studies, change evaluations) to develop/optimize manufacturing ready production workflows or test methods.

  • Evaluate manufacturing processes and/or develop new manufacturing processes for new products or process improvements

  • Provide technical oversight and coordination of development and pilot plant builds within the Pilot Plant production area supporting multiple projects and initiatives

  • Ensure successful transfer of knowledge into manufacturing and the sustaining support teams

  • Monitor, trend and analyze results from development and pilot lots during the NPI process; track off-targeted production outputs, troubleshoot/perform root cause analysis, and make technical and compliance related recommendations as required.

  • Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide recommendations based on results.

  • Author technical documents, such as plans/protocols, engineering reports, SOPs, or other manufacturing related documentation.

Requirements:

  • Work experience in production, pilot plant, and/or product development following GMP best work practices and techniques is required.

  • Work experience with NPI projects, design change control programs, and understanding product lifecycle management

  • Experience with DOE techniques, statistical analysis, and statistical process controls.

  • Experience with various manufacturing process workflows, automation and equipment used to support production of multiple product lines.

  • Demonstrated ability to accomplish goals while working across departments is required.

  • Demonstrate ability to problem solve, provide technical evidence for support and make decisions.

  • Ability to communicate effectively and build strong relationships across multiple departments.

  • Ability to work in fast-paced environment; easily adaptable to changing priorities.

  • Knowledgeable of ISO 13485, ISO 14971, 21 CFR 820 / 11

Experience/Education: B.S./M.S./ PhD in Chemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics, Biological Sciences, Materials Science or Physical Chemistry or equivalent disciplines with: 2-4+ years of industry experience with a PhD, 5-7+ years of industry experience with a MS/BS

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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