Plastics Process Engineer II

Responsibilities

• Own assigned molding processes and ensure adherence to validated parameters
• Apply scientific molding principles to establish and maintain robust process windows
• Monitor process performance using SPC tools to analyze trends and reduce scrap
• Support cycle time reduction, yield improvement, and OEE optimization projects
• Lead troubleshooting for common molding issues such as short shots, flash, splay, and burns
• Collaborate with Maintenance and Tooling teams to resolve equipment and mold-related issues
• Provide technical guidance to operators and technicians on setup and process adjustments
• Author and execute IQ/OQ/PQ protocols for molds and equipment
• Maintain accurate process documentation and validation reports per cGMP and ISO 9001 requirements
• Drive small-scale improvement projects using Lean/Six Sigma methodologies
• Participate in CAPA investigations and root cause analysis for process deviations
• Ensure compliance with cleanroom protocols and regulatory standards for biopharmaceutical components

Requirements

• BS in Plastics, Polymer, Mechanical, Chemical, or Manufacturing Engineering
• 3–7 years of injection molding experience in a regulated environment
• Hands-on experience with Arburg injection molding machines and auxiliary equipment
• Working knowledge of Scientific Molding, SPC, and basic DOE principles
• Strong documentation and communication skills

About the Company

Repligen is a global leader in bioprocessing, dedicated to inspiring advances in the production of biologic drugs that improve human health worldwide. We provide innovative technologies and solutions that help set new standards in the biopharmaceutical industry.