California Licensed Process Engineer

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