Engineer, Biotech Process Engineering (JP10544)
HybridThousand Oaks, California, United States
Job Summary
Transfer purification drug substance processes from laboratory to manufacturing facility and perform process improvements. Provide technical support for scale-up, technology transfer, and clinical or commercial manufacturing operations while offering validation support for late-stage processes. Execute routine process monitoring, troubleshooting, data trending, and statistical analysis. Support technical direction for deviations, CAPAs, and change controls. Collaborate with manufacturing, quality, and regulatory functions to represent process development. This role supports the Drug Substance Technology Engineering team at a Thousand Oaks facility, translating developmental processes to commercial reality for patients using single-use technology.
Required Qualifications
- Must have biotech background/experience
- Must have purification experience
- Master's degree
- Bachelor's degree
- Associate's degree and 7 years of Engineering or Operations experience
- High school diploma / GED and 8 years of Engineering or Operations experience
- Must have biotech background/experience, plus must have purification experience
- Strong understanding of data analysis tools
- Knowledge of biologics purification processes/ equipment; scale up factors from, chromatography
- Manufacturing experience must be biotech experience
- Must be able to lift 50 lbs
Desired Qualifications
- Master's Degree in Chemical or Biochemical Engineering
- 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
- Background in biologics tech transfer into commercial facilities
- Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, process deviations, raw materials to growth and quality attributes
- Strong capability of analysis, troubleshooting and problem solving
- Ability to develop and follow detailed protocols
- Independently motivated with ability to multi-task and work in teams
- Excellent written and verbal communication skills with technical writing and presentation experience
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