Process Development Engineer

About this role

A newly created Process Development Engineer I role in Emeryville focused on advancing manufacturing processes for drug-releasing microspheres. You'll collaborate closely with the Process Development team to validate custom equipment, identify improvements, troubleshoot issues, and prepare for GMP-scale production while maintaining comprehensive documentation in a quality management system.

What you'll do

• Oversee and validate manufacturing processes using custom equipment
• Identify and implement process improvements and troubleshoot complex technical issues
• Develop and generate manufacturing method standard operating procedures (SOPs)
• Maintain controlled inventory of equipment parts and records within QMS
• Conduct hands-on process development and technology research in lab settings
• Generate reports and maintain detailed documentation for GMP compliance

What they're looking for

• Process chemistry or mechanical engineering knowledge
• GMP manufacturing experience
• Process equipment maintenance and troubleshooting
• Process automation familiarity
• Quality Management System (QMS) record keeping
• Critical problem-solving and analytical thinking
• Organization and attention to detail
• Technical documentation and SOP writing