Process Engineer Fill Finish - Life Sciences - Ireland - 12-Month Contract
Our client, a global pharmaceutical company located on Ireland's picturesque west coast, is seeking a Process Engineer to join their state-of-the-art pharmaceutical facility in the historic province of Connacht.
Key Responsibilities:
* Process Engineer for Fill Finish Manufacturing site
* Leverage detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification.
* Responsible for single-use design, onboarding, and qualification. Act as site representative on cross-site teams for standardization of single-use assemblies and procedures.
* Work with supplier technical teams to maintain good relationship. Technical representative on site cross-functional team for design updates and introduction of new single use to site.
* Author of process flow diagrams for new product introductions/technology transfers. Responsible for aligning PFD between products and standardizing for NPI.
* Aligns with NPI Lead for product transfer on requirements for new products or process improvements.
* 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 and presentations to document and communicate project status to internal and external stakeholders.
* Ensure compliance with safety, regulatory, and compliance expectations.
Requirements:
* Third-level degree in Chemical Engineering, Bioprocess Engineering
* Experience in biopharmaceutical industry
* Biologics experience with at-scale manufacturing in fill-finish facility in a technical role
* Experience with new product introductions/technology transfers to fill-finish manufacturing facility
* Experience in single-use technology
* Experience in isolator technology
* Experience in SAP/Trackwise