Process Engineer

Job DescriptionA Process Engineer is required on a PERMANENT basis by CareerWise Recruitment for our Waterford-based Biopharmaceutical and Medical Device Client.To provide Process Engineering shift support to existing business as usual daily functions and on-going continuous improvement prefilled syringe processes. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment. Role of this position The main area of work is to own and deliver batch release related activity to support the PFS Fill and Inspection Operations - such as investigations, Root cause analysis, CAPA generation and closure, work order investigations and addressing batch comments from the quality team.In addition, supporting projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualification.Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.Other responsibilities will be to provide support on the existing Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.Support commercial manufacturing through delivery of key performance metrics (SQDCI). JOB REQUIREMENTS 1+ more years' relevant of experience in a highly regulated GMP environmentDegree in an Engineering disciplineStrong problem solving and communication skillsStrong documentation/protocol generation and execution skillsBatch release experienceRoot cause analysis and Investigation exposureExperience in syringe/vial filling and inspection would be a distinct advantageExperience in sterile manufacturing