Summary: Our client is a biopharmaceutical company that is looking for a Process Engineer to join their team in Carlow. The successful candidate will provide technical support for new product introductions and commercial manufacturing. Responsibilities: Coordinate, execute, and document qualification, validation, and process studies and additional product programmes as required. Design, author, review, approve, and execute process, qualification, and validation documentation in line with standard approval processes. Execute development and qualification studies across commercial and non-commercial products. Support the development and qualification of new processes and new equipment, where applicable. Provide technical support for commercial manufacturing and new product introduction activities. Lead and support investigations, troubleshooting, root cause analysis, change controls, and risk assessments. Ensure compliance with cGMP, regulatory requirements, and the Quality Management System through documentation completion, audit participation, and closure of corrective actions. Represent Technical Operations at cross-functional meetings and support audit readiness activities. Support continuous improvement initiatives using MPS and Lean tools. Apply technical knowledge to support technical documentation and sound technical decision-making. Work collaboratively to promote a safe, compliant, and high-performing site culture. Carry out other duties as assigned. Qualifications & Experience: Bachelors Degree or higher, ideally in Science, Engineering, or a related technical discipline. Minimum of 1 years experience in a manufacturing environment, preferably within a GMP setting. Knowledge of cGMP and relevant Irish, European, and international regulatory requirements. Proficiency in Microsoft Office and relevant job-related computer applications.