Process Engineer

About the Role We are seeking a Process Engineer to support manufacturing operations within a leading biopharmaceutical facility. The successful candidate will work closely with cross-functional teams to ensure reliable, compliant, and efficient manufacturing processes while driving continuous improvement initiatives. Key Responsibilities Provide day-to-day engineering support for manufacturing operations. Support process optimization, troubleshooting, and root cause investigations to improve process reliability and performance. Work closely with Manufacturing, Quality, Validation, and Maintenance teams to resolve process-related issues. Assist in process monitoring, data analysis, and implementation of continuous improvement initiatives. Support equipment qualification, process validation, and change control activities where required. Ensure all engineering activities are carried out in compliance with GMP, safety, and regulatory requirements. Provide engineering support for downstream processing equipment, including chromatography skids and ultrafiltration/diafiltration (UF/DF) systems, ensuring reliable operation, troubleshooting, and process optimization. Prepare and maintain technical documentation, SOPs, engineering reports, and deviation investigations. Participate in project activities related to process improvements, equipment upgrades, and technology transfer. Requirements Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related engineering discipline. Experience within the biopharmaceutical or pharmaceutical manufacturing industry. Experience supporting upstream and/or downstream manufacturing processes, with downstream processing experience preferred. Hands-on experience with downstream biotechnology equipment such as chromatography skids and ultrafiltration/diafiltration (UF/DF) systems is highly preferred. Hands-on experience with DeltaV DCS is highly preferred. Familiarity with GMP regulations and regulated manufacturing environments. Strong analytical and problem-solving skills with the ability to work collaboratively across multiple functions. Excellent communication and stakeholder management skills. Preferred Experience Biologics manufacturing experience. Exposure to process validation, CAPA, deviation investigations, and change controls. Experience supporting continuous improvement initiatives and process optimization projects.