Process Engineer

Department
Process Development and Production

Location
San Diego, CA

Summary Description
The Process Engineer will assist in the design, implementation and sustainability of manufacturing processes from feasibility through scale-up and commercial manufacturing. Emphasis for this role focuses on ensuring robust systems using accepted GMP design controls. Candidate shall be familiar with the design qualification process, and have relevant experience to bio-processing methods. Candidate should be comfortable with good documentation practices, working within a regulated environment and making data driven decisions.

Qualification Requirements: 

  • 3-5 years of relevant experience with a BS degree in chemistry, biological sciences or engineering preferred
  • Excellent written and interpersonal skills required
  • Strong data analysis, troubleshooting and problem solving skills required
  • Experience working with cross-functional teams to determine system requirements and specifications
  • Design and execution of controlled experiments to optimize processes, yield and/or quality
  • Process development, scale-up, technology transfer and equipment/process validation activities
  • Authoring of standard operating procedures, technical reports and related GMP documentation
  • Understanding of practical statistics and identification of critical process parameters
  • Demonstrated ability to execute medium complexity tasks and experiments independently

Desirable Skills and Knowledge:

  • Equipment monitoring, maintenance and calibration
  • Experience in the biotech or pharmaceutical industries
  • DOE and use of statistical analysis software (JMP)
  • Working knowledge of design (Solidworks) and fabrication of parts and assemblies
  • Ability to read and understand drawings, schematics, tolerances and limits
  • Understanding of 21 CFR parts 11, 210 and 211 a plus
  • Working within a controlled production environment
  • Working with potentially infectious materials

Travel:

Occasional

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