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.
* Start-up/pilot plant skills - Applicants should be energetic and personable, organized, self-motivated, and capable of working independently, and as part of closely knit teams
* Technical knowledge (theory and practice) of aseptic manufacturing; experience working in high technology / Engineering disciplines with exposure to Aseptic processing.
* In depth understanding of Autoclave, CIP and SIP systems, and Clean Utilities.
* Design of Experiment and associated statistical techniques
* Pharmaceutical product development project life-cycle experience
* Strong report-writing and verbal communication skills
* Research skills
* Innovation and creativity skills; demonstrated ability to provide technical solutions for complex problems through equipment knowledge.
* Project management skills
* Structured Problem-solving skills – Statistical
* Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.
* Strong knowledge of current Good Manufacturing Practices and US / EU regulations.
* Ability to act as Process Engineer SME in regulatory audits