BioProcess​/NPI Engineer in San Jose, CA

Bio Process/NPI Engineer

Represents reagent operations in new product teams responsible for the development, scale up, validation, creating new product documentation and transfer of production processes to Operations. May determine methods and procedures on new assignments.

Duties and responsibilities:

• Develop, scale up and setup the manufacturing processes to optimize process flow, reduce variability within the process, and improve operating capabilities.
• Work with R&D team to develop and validate the QC test methods.
• Prepares and submits SOP’s, WI’s, BOM’s, routings and standard costing for new product into SAP
• Works with the team to design, write and execute Gage R&R, scale up, stability, and validation studies and associated reports.
• Promotes a safe work environment.

Education and Experience:

• Requires a minimum of a Bachelor’s degree in biological sciences with 5 years of relevant experience or Master’s degree with minimum of 3 years of relevant experience.
• A minimum of 3 year experience in a FDA or ISO regulated medical device production environment.
• Knowledge in antibody techniques, molecular biology techniques, instrumentation, and assays performed
• Experience in developing the manufacturing process and QC test method is must.
• Experience in document creation, BOMs, Routings, etc.
• Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
• Experience in SAP is highly preferred
• Experience in statistical analysis, 6 Sigma Greenbelt or Lean Manufacturing certification preferred.