Process Engineer – Fill Finish- Sligo
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.
• 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
• 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