- 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.
Please note, we do not require agency assistance with this role.