QC Specialist Location: Shannon, Ireland Our client is a gene therapy company that works with gene therapy discovery, development and GMP manufacturing. They have headquarters in London and the USA and have recently redesigned exciting new labs with cutting edge technology and the ability to work to a higher standard and increase their capacity of production. They are currently seeking a QC Specialist to join their QC team and ensure continued GMP compliant activities to support the manufacture and release of the gene therapy products. Key responsibilities include: Write, review and update SOPs and related documentation for QC. Liaise with cross-functional departments to introduce equipment into the new QC labs including generation of life cycle and qualification documents. Participate in method validation and or tech transfer execution as needed. Generate method validation/technical transfer protocols and/or reports. Perform routine analytical testing for in-process and release samples. Support testing at external contract labs for raw materials and final product. Training/mentoring of junior analysts. Operation and maintenance of laboratory equipment. Record Out-of-Specification and non-conformances. Lead investigations and implementation of corrective actions Provide Subject Matter Expertise as part of regulatory inspections and site audits. Maintain QC facilities to meet GMP requirements Support with maintaining the QMS and controlling of documents and assuring the data integrity of all data produced. Responsible for ensuring that any GMP documentation within its own area of responsibility, is closed timely and in a RFT state. Skills Required: BSc in a scientific discipline e.g. Biochemistry, Chemistry. Minimum 3 years experience working in a GMP environment. Experience in working with any or numerous of the following methods; qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction, Spectrophotometry. Experience with mammalian cell culture and/or flow cytometry preferred. Proficiency in Microsoft Office software preferred, specifically Word, Excel and PowerPoint. The ability to work in a fast-paced environment is essential. #J-18808-Ljbffr
Process Engineer Location: Shannon, Ireland Our client is a gene therapy company that works with gene therapy discovery, development and GMP manufacturing. They have headquarters in London and the USA and have recently redesigned exciting new labs with cutting edge technology and the ability to work to a higher standard and increase their capacity of production. They are currently seeking a process engineer to support their manufacturing facility including its operations, process improvements as well as supporting tech transfer projects. Key responsibilities include: Support Capital project design and review activities, particularly Single use equipment items & setup. Support Process Technical transfer activities Coordination of vendor activities for Commissioning & Qualification, Maintenance & Calibration and/or process improvements. Assist with the implementation and development of applicable engineering specifications and standards. Provide SME input to on-site SH&E programmes. Assist with the implementation, maintenance and measurement of a framework for compliance and continuous improvement in quality performance. Develop and manage strong relationships across teams to remove barriers in order to ensure the ultimate performance efficiency. Assist with the identification and implementation of technology based and work practice solutions that are designed to reduce waste and overall cost. Responsible for ensuring that own work complies with GMP, Data Integrity and GDP and is undertaken in accordance with applicable procedures. Responsible for ensuring that any GMP documentation assigned to me is closed timely and in a RFT state. Skills Required: Qualified to Degree Level in a related Engineering or Science discipline. Min 5 years’ Experience of working within a Biopharmaceutical environment in a Process engineering role. Cleanroom working knowledge. Knowledge of biopharmaceutical process operations including Media & Buffer prep, Upstream & Downstream. Experience of working in a start-up is desirable. Experience with Fill Finish operations is desirable. #J-18808-Ljbffr
