California Licensed Process Engineer

Job Summary

A company is looking for a Staff Process Engineer.

Key Responsibilities

• Review equipment drawings and specifications to ensure compliance with process requirements and regulatory standards
• Plan, execute, and oversee manufacturing and packaging projects, ensuring alignment with product launch timelines and regulatory requirements
• Drive continuous improvement initiatives to streamline manufacturing and packaging processes, enhancing compliance and productivity

Qualifications and Requirements

• Bachelor's degree in Engineering (Mechanical, Chemical, or Process), Regulatory Affairs, or a related field
• Minimum of 7-11 years of experience in pharmaceutical manufacturing and packaging, with expertise in process engineering
• Strong background in equipment commissioning, instrumentation, and process validation
• Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to manufacturing and packaging
• Proficiency with quality systems, including change control and quality events