Process Engineer

Position Overview

Key Responsibilities

• Lead approved projects and drive them to completion while maintaining project timelines and budget objectives for small to medium projects.
• Collaborate with cross-functional teams to identify, evaluate, develop, and implement process improvements that drive operational excellence and process reliability, based on supporting data, technical knowledge, engineering principles, and current Good Manufacturing Practices (cGMPs).
• Collaborate on the design of process equipment; assist vendors during installation and commissioning of new process equipment; review engineering specifications across pneumatics, electronics, controls, and other integration facets.
• Participate in investigations to identify root causes for process discrepancies or out-of-specification (OOS) results, and implement effective corrective and/or preventive actions (CAPAs) to ensure product quality and customer safety.
• Utilize good engineering practices and change management systems to document equipment commissioning, qualification, and change history; author and execute engineering studies using experimental design and statistical analysis principles.
• Evaluate and improve process controls to ensure reliable, repeatable manufacturing by updating critical instrumentation systems, process drawings, manufacturing instructions, and procedures; understand the control strategy between Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).