Process Engineer III/IV

Organization
NanoString Technologies
Job Location
Seattle, WA 98109
Salary
Competitive
Benefits

Comprehensive

Job Description

The Process Engineer is responsible for developing, implementing, and troubleshooting new methods used in manufacturing in support of the release of new products. This individual is responsible for the design and scale-up of processes, instruments, and equipment from the laboratory through the pilot plant and manufacturing process. In addition, this individual may establish operating equipment specifications and improve manufacturing techniques, and is involved in new product scale-up, process improvement, and technology transfer activities.

Essential Functions:

  • Draft SOPs, Batch Records, Specifications, and other documentation associated with process transfer to a Manufacturing environment
  • Perform and document Risk Assessments
  • Design, document and summarize Verification and Validation studies
  • Write protocols, experimental summary reports, quality documents and other scientific literature associated with projects
  • Work cooperatively in a timeline-focused, matrixed, team environment
  • Present data to product/process development teams and management representatives
  • Analyze large, complex data sets using spreadsheets and/or other data analysis packages
Requirements
  • Ph.D. or M.S. in related life science discipline
  • Minimum of 6 years of industry experience in process development and technology transfer
  • Understanding of product development lifecycle (development, V&V, design control, design transfer, sustaining support)
  • Extensive experience with Design-Of-Experiments (DOE) and associated analysis
  • Experience with life science research tools process development
  • Experience working with RNA/DNA/Protein/Antibody assays and protocols
  • Experience with HPLC method development
  • Comfort working on robotics such as the nCounter instrument or liquid handing systems
  • Experience with GMP production and batch record review
  • Experience with ISO and FDA process development standards and principles including definition of critical process parameters and critical quality attributes
  • Practical experience with protein/antibody conjugation equipment used in a manufacturing environment
  • Excellent technical writing and record keeping abilities
  • Excellent analytical skills and familiarity with statistical analysis software such as JMP, Minitab, R, etc.
  • Familiarity with ISO 13485 or working within QSR environments preferred
  • Experience in Risk Management and performing Risk Analysis  e.g. FMEAs preferred
  • Comfortable working within electronic quality management systems (EQMS) e.g. MasterControl preferred
About Our Organization

NanoString Technologies is a publicly held provider of life science tools for translational research and molecular diagnostics. The company's technology enables a wide variety of basic research, translational medicine and in vitro diagnostics applications.

NanoString's products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under direction of Dr. Leroy Hood. The company was founded in 2003 with an exclusive license to develop and market the technology. In 2008, NanoString launched its first commercial instrument system and began international sales operations with its first multiplexed assays for gene expression analysis. In 2010, the company launched new applications for the system to support microRNA analysis and copy number variation detection, and in 2013 launched Prosigna, its first in vitro diagnostic product for prognosis of early stage breast cancer.

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