Job Description:
We are seeking a highly skilled Pharmaceutical Manufacturing Specialist to join our team at our state-of-the-art pharmaceutical facility in Ireland. Located on the picturesque west coast of Ireland, our facility is situated in the historic province of Connacht, neighboring the Atlantic Ocean.
* Leverage your detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification processes.
* Be responsible for single use design, onboarding, and qualification. Represent the site on cross-site teams for standardising single use assemblies and procedures.
* Collaborate with supplier technical teams to maintain good working relationships. Technical representative on site cross-functional teams for design updates and introduction of new single use to site.
* Author process flow diagrams for new product introductions/technology transfers. Ensure PFD alignment between products and standardise for NPI.
* Technical SME for investigations, responsible for process improvements and monitoring of process efficiency.
* Author gap assessments, facility fit studies, process safety and risk assessments for NPI.
* Author scientific reports and technical documentation/presentations to document and communicate project status to internal and external stakeholders.