Process Engineer (Aseptic Processing Facility)

Role Summary:Our client, based in Co. Tipperary, has an urgent requirement for a Process Engineer to provide specialist support for equipment qualification and operations initially in a start-up environment.The Process Engineer is also required to provide technical support for clean utilities and facility qualification as needed.This role focuses on resolving technical and engineering issues, providing technical support and troubleshooting, investigation closeout and maintaining the qualification status of a new aseptic plant and equipment.Core Duties and Responsibilities:Support the design and implementation of aseptic processing technologies and procedures.Lead process equipment commissioning and qualification activities for a new aseptic facility.Develop process understanding; perform gap analysis and FMEAsLead contamination reduction and investigation projectsLead major equipment related investigations and implement equipment CAPA and performance improvements.Develop and support aseptic practice training as necessary.Drive the adoption of new aseptic processing technologies and best practices in manufacturing processesDevelop metrics to measure and continually improve aseptic processing practices within manufacturing and process development.Provide technical guidance on change controls and how they might impact aseptic processing.Prepare and review technical and compliance testing protocols and reports.Provide technical training on process and equipment as required by Operations.Minimum Qualifications and Experience:Degree in Chemical, Industrial or equivalent Engineering disciplineAdvanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantageA minimum of 4-5 years industrial Engineering experience of which 2-3 years will be in an aseptic processing environment.Experience in Fill-Finish of injectable products is highly desirable.