Job Description
Process Engineer Team Horizon is seeking a Process Engineer for a leading pharmaceutical company in Sligo. Joining team of 8, reporting to the NPI Technical Manager – team is divided into NPI/Tech Transfer and Manufacturing Support. Will be based at the Biologics site – parental drug product fill finish facility, supporting design, qualification, and management of single use technologies. Will interact with vendors/manufacturers and review drawings for connectors/filters etc. Will also work closely with manufacturing, ensuring Operators are trained in single use technologies. Will be involved in investigations/troubleshooting of issues as well as process improvements. Why you should apply: * Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work. * You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo. What you will be doing: * 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. What you need to apply: * 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. * Experience in single use technology. * Experience in isolator technology. * Experience in SAP / Trackwise. * Single use Technology: design and qualification in drug product/Fill finish or drug substance is also applicable. * Experience dealing with vendors