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Process Development Engineer

3 months ago

Santa Clara, United States Dawar Consulting Full time
Job Description
Our client, a world leader in diagnostics and life sciences, is looking for a Process Development Engineer based out of Santa Clara, CA.

Job Duration: Long Term Contract (Possibility Of Extension)

Responsibilities:

  • Provide hands-on process support including troubleshooting and improvement initiatives
  • Create and approve Work Instructions, Production Records, and other documentation for processes
  • Advise on improvements and ensure controls are demonstrated through completion of method validation, or computer system validation
  • Support or lead investigations for identified non-compliance observations (for example, Corrective and Preventative Actions (CAPAs) and Non-Conformance Reports (NCRs)
Education/Required Skills:
  • BS in the relevant field
  • 5-8 years in Medical Device or In Vitro Diagnostics
  • Cartridge manufacturing, microfluidic devices or DNA Sequencing is preferred.
  • Prior Experience with process mapping, document generation, and testing in production environments is highly beneficial.
  • Experience in statistical analysis, DOE, and utilizing tools like Minitab for data analysis and interpretation.
  • Experience in raw material characterization, including visual inspection, chemical testing, and surface characterization.
  • Proficiency in process validation, equipment validation, and ensuring compliance with relevant standards and regulations.

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

Please apply or send your resume to hr@dawarconsulting.com / akansha@dawarconsulting.com