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
