Job Description
Summary: Our client, is a global biopharmaceutical company based in Waterford, looking for a Process Engineer who will provide Process Engineering support on-going continuous improvement initiatives and capital projects. Support the manufacturing of Auto Injector commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused Engineering Team in a controlled not classified (CNC) environment. Responsibilities: The Product Supply APU is currently expanding and consists of multiple platforms for the PFS inspection, assembly, labelling, cartooning, of autoinjectors and prefilled syringes. The platforms range from manual processes through to high-speed, high volume automated production lines to include Mikron assembly lines, Dividella cartoners, Krones labellers and Antares AIOs. Support delivery of continuous improvement projects to existing equipment. Work closely with various departments, such as MSAT, Technical Development, Quality Assurance, and Supply Chain. Lead and coordinate project and process engineering activities related to the development of new and existing manufacturing capacity. Utilisation of knowledge gained from existing manufacturing technologies to aid in the development of new technologies with the goal of implementing higher output and yield. Ensure safety compliance, providing technical and engineering support for process and equipment failures, identifying and implementing process and product improvements, supporting qualification of new products/processes, analysing machine performance data, and managing improvement projects within budget and time constraints. Support new product introductions and capacity expansions, including new vendor selections, maintenance planning, design changes, change controls, OEE improvement, yield improvement, etc. Lead systematic technical root cause investigations. Support all company safety and quality programs and initiatives. Qualifications & Experience: Degree in an Engineering discipline. Relevant experience in a highly regulated GMP environment. Experience in high volume assembly, cartooning or packaging would be a distinct advantage. Equipment working in capital projects environment introducing new equipment. Strong documentation/protocol generation and execution skills. Skills: GMP Cartooning Assemblying Packaging Capital Project Execution skills