Process Simulation Specialist
A fantastic opportunity exists to join a global pharmaceutical client in their Leinster site. The team is looking for a Process Simulation Specialist to support multiple capital projects taking place onsite.
This role involves working on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Key responsibilities include designing, authoring, reviewing, approving, and executing process simulations studies in support of new product introduction and ongoing manufacturing support.
Additionally, you will provide technical input into quality notifications by authoring, reviewing, and approving process simulation related investigations. You will also design, author, review, approve, and execute commercial and process simulation qualification/validation documentation and studies in line with the standard approval process.
Another key aspect of this role is performing data analysis and making informed decisions/recommendations around conclusions reached from data analysis. You will also support continuous improvement through Lean Six Sigma methodologies, leading and actively participating in projects, system failure investigations, and investigation reports. Execution/development of change controls to support the Process Simulation process, contribution to Kaizen events, and performing root cause analysis of system failures, substandard performance using standard tools and methods are also expected.
The ideal candidate will hold a Bachelor's Degree or higher, preferably in a Science, Engineering, or other Technical Discipline. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices is essential. Report, standards, policy writing skills, equipment and process validation, sterile filling processes and equipment, proficiency in Microsoft Office and job-related computer applications are also required. Lean Six Sigma Methodology experience is desirable.
If you have the required skills and qualifications, please consider applying for this exciting opportunity.