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PE Global is currently recruiting for a Process Engineer for a leading biopharmaceutical clients based in Sligo
This is an initial 12-month contract position.
Role
* 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.
* 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.
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