Process Engineer II

Role Overview

The Process Engineer II provides knowledge and expertise to support pharmaceutical process development, technology transfers, and commercial products. They oversee the implementation of new technologies, drive continuous process improvements, and innovation for the Irvine manufacturing site.

What You Will Do

Support technology transfers, contribute to technical evaluation of new processes, own knowledge of pharmaceutical manufacturing process technologies, and participate in the creation of manufacturing procedures and SOPs.

Why It Might Be a Fit

This role requires an advanced level of proficiency in late-stage process development or clinical and commercial manufacturing operations, excellent interpersonal skills, and a strong understanding of GMP manufacturing or process development of parenteral products.

Requirements

• Strong understanding and hands-on experience in GMP manufacturing or process development of parenteral products
• Working knowledge of risk-based decision-making and stage-appropriate implementation strategies
• Capable of working with global and cross-functional teams
• Experience with root cause analysis and product quality impact assessments
• Working knowledge of GMP production-related IT systems such as SAP and LIMS

Benefits

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• 401K