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 FMEAs
* Lead contamination reduction and investigation projects
* Lead 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 processes
* Develop 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 discipline
* Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage
* A 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.