Plastics Process Engineer II

Make a global impact—join Repligen. We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us! The Plastics Injection Molding Process Engineer II is responsible for developing, optimizing, and maintaining robust molding processes that ensure consistent product quality, operational efficiency, and safety compliance. This mid-level role serves as a technical leader in process development and troubleshooting, supporting production, tooling, and design teams to improve yields, reduce downtime, and enhance overall manufacturing performance. This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work. 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; analyze trends to reduce scrap and downtime Support cycle time reduction, yield improvement, and OEE optimization projects Lead troubleshooting for common molding issues (short shots, flash, splay, burns) and implement corrective actions 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 under supervision of senior engineers Maintain accurate process documentation, setup sheets, and validation reports per cGMP and ISO 9001 requirements Participate in change control activities for process improvements and equipment upgrades Drive small-scale improvement projects using Lean/Six Sigma methodologies. Support kaizen events and implement standard work for mold changes and machine setups Assist in automation integration (robots, vision systems, CMM) and auxiliary equipment optimization Ensure compliance with cleanroom protocols (ISO 14644) and contamination control procedures Participate in CAPA investigations and root cause analysis for process deviations Maintain adherence to regulatory standards for biopharmaceutical components (USP <87>/<88> , ISO 9001) Qualifications BS in Plastics/Polymer, Mechanical, Chemical, or Manufacturing Engineering (or equivalent) 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 Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated salary range for this role, based in the United States of America is $85,289-110,374. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer. Thank you for your interest in Repligen! Working at Repligen means being part of a team that is excited to find new and creative ways to overcome challenges in bioprocessing — and to help our customers make a difference in the world.