Senior Process Engineer

Summary: Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at our Holly Springs site. This role is fully onsite and requires strong hands-on technical expertise with Clean-In-Place (CIP) systems, process design, and supporting utilities. The Process Engineer will be responsible for the design, review, and optimization of CIP systems and associated utilities to ensure robust, compliant, and efficient manufacturing operations. The ideal candidate has deep technical knowledge of CIP system design, understands the interaction between process equipment and utilities, and can collaborate cross-functionally in a GMP environment. Responsibilities & Requirements: Lead and support CIP system design, review, and optimization for manufacturing processes Perform process design activities, including development and review of process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and system layouts Review and assess system design documentation to ensure alignment with operational, safety, and regulatory requirements Provide technical expertise in utilities supporting CIP systems, including water systems, steam, chemical distribution, and waste handling Support implementation of process and utility design changes in a GMP environment Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, Quality, and Facilities Ensure designs meet GMP, safety, and regulatory compliance standards Participate in troubleshooting, continuous improvement initiatives, and process optimization efforts Education & Experience: Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline Proven experience as a Process Engineer in a regulated pharmaceutical or biotechnology environment Strong hands-on experience with Clean-In-Place (CIP) systems Demonstrated experience in: System design reviews Process design and documentation Utility design and utility-system integration related to CIP Solid understanding of GMP principles and regulated manufacturing environments bility to work 100% onsite in Holly Springs, NC Experience supporting large-scale biopharmaceutical manufacturing operations Familiarity with commissioning, qualification, and validation activities related to CIP systems Strong communication skills and ability to work cross-functionally

Created: 2026-03-10