Process Engineer Job Opportunity at PE Global
We are currently recruiting for a Process Engineer to join our team in Sligo, Ireland.
Role Overview:
* Work as a 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
* Understand and ensure compliance with safety, regulatory and compliance expectations
* Other duties as assigned
Requirements:
* Third level degree in Chemical Engineering, Bioprocess Engineering
* 3-5 years' experience in biopharmaceutical industry
Essential Experience:
* 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
Interested candidates should submit their application.