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Engineer 2, Process Development

Illumina
USA
Full-time
Junior · 2+ years experience
Onsite
Discovered 3 weeks ago
Communication

Full Job Posting

Responsibilities:

  • · Partner with R&D, Manufacturing, Supply Chain, and Quality teams to design and develop robust, high-volume manufacturing processes using Critical Parameter Management (CPM) principles.
  • · Design, execute, and analyze controlled experiments, including Design of Experiments (DOE), to optimize processes, improve yield and quality, and implement solutions in production environments.
  • · Drive product and process change management activities, including product configuration within ERP systems, to support successful product launches.
  • · Conduct root cause investigations using methodologies such as 8D, model-based problem solving, and statistical analysis to identify and resolve technical and compliance-related issues.
  • · Serve as a subject matter expert for critical-to-quality (CTQ) and critical-to-performance (CTP) process characteristics.
  • · Apply process engineering tools and methodologies, including FMEA, SPC, Gauge R&R, Critical Parameter Management, and Design for Manufacturability (DFM), to improve process capability and robustness.
  • · Lead technical project teams, drive execution of key deliverables, and identify risk mitigation strategies to achieve project milestones.
  • · Define technical requirements, create process documentation, and facilitate the transfer of manufacturing and quality control processes from development through scale-up and commercialization in a regulated environment. Requirements:
  • · Strong written and verbal communication skills, with the ability to effectively collaborate across multiple functions is required.
  • · Proven ability to achieve objectives in a cross-functional team environment is required.
  • · Excellent analytical, problem solving, and critical-thinking skills are required.
  • · Experience with statistics, Statistical Process Control (SPC), and Design of Experiments (DOE) is an advantage.
  • · Experience in high-volume manufacturing within a high-tech consumables or related industry is an advantage.
  • · Familiarity with product development processes and project management methodologies is an advantage.
  • · Define technical requirements, create process documentation, and facilitate the transfer of manufacturing and quality control processes from development through scale-up and commercialization in a regulated environment.

Education and Experience:

  • B.S./M.S. in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science equivalent with 2+ years of relevant experience in production sustaining, process development, scale-up, and validation. • PhD in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science with relevant experience in process development. Experience with production sustaining, process development, scale-up, and validation is an advantage.
  • · Strong written and verbal communication skills, with the ability to effectively collaborate across multiple functions is required.
  • · Proven ability to achieve objectives in a cross-functional team environment is required.
  • · Excellent analytical, problem solving, and critical-thinking skills are required.
  • · Experience with statistics, Statistical Process Control (SPC), and Design of Experiments (DOE) is an advantage.
  • · Experience in high-volume manufacturing within a high-tech consumables or related industry is an advantage.
  • · Familiarity with product development processes and project management methodologies is an advantage.
  • B.S./M.S. in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science equivalent with 2+ years of relevant experience in production sustaining, process development, scale-up, and validation.
  • PhD in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science with relevant experience in process development. Experience with production sustaining, process development, scale-up, and validation is an advantage.

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