Process Development Engineer

5 days ago


Somerset, United States Astrix Technology Full time
Job Summary:

As a Process Development Engineer at Astrix Technology, you will support and lead portions of the Component Qualification process. This role involves leading, planning, and executing process development activities from protocol generation through data analysis. You will also support Process Validation activities for Clinical Trial Manufacturing readiness and collaborate cross-functionally to design, develop, or improve and implement new manufacturing processes for clinical trial manufacturing enhancement.

Key Responsibilities:

• Support and lead portions of Component Qualification process

• Lead, plan, and execute process development activities from protocol generation through data analysis

• Support Process Validation activities for Clinical Trial Manufacturing readiness

• Collaborate cross-functionally to design, develop, or improve and implement new manufacturing processes for clinical trial manufacturing enhancement

Requirements:

• PhD in Chemical Engineering, Bio-engineering, or other related discipline

• Understanding of Medical Devices Design Controls is required

• Familiarity with statistical analysis and design of experiments

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