Process Engineer (Sterile)
Process Engineer (Sterile) - County Waterford. In this role you will provide engineering support to the sterile fill-finish function, in the design, commissioning and qualification of equipment and processes to facilitate the manufacture of new and existing products. Core Responsibilities: • Provide engineering support to Sterile Fill-Finish development teams and projects. • Develop and support new manufacturing processes and technologies. • Understand equipment operation in detail. • Define and review equipment specification and associated test documentation. • Support project delivery through FAT, SAT and IOQ involvement as needed. • Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing. • Identify means to improve processes, increase efficiencies and reduce costs. • Strong focus on disciplined root cause analysis. • Liaise with vendors on disposable technology and integration into the process. • Development of process cleaning and sterilization cycles. • Development of critical process parameters for the process and development of process capability and deviation monitoring. • Monitor process risk and ensure mitigations are in place as required. • Benchmark other industries and organisations to ensure best practice is in use. Interested applicants should have: Minimum of degree level in engineering or related discipline. Minimum 1 year's Process Engineering experience within a relevant Pharma environment (preferably within a sterile manufacturing environment. Ability to understand engineering processes through a logical, data driven, hands on approach. Use of FMEA, FMECA and Risk assessment techniques. This job originally appeared on RecruitIreland.com.
384 days ago