Technical Operations Engineer
Life Science Consultants Ltd
Cork
Do you have an Engineering or Science degree with at least one year's experience working in a pharmaceutical or bio environment? Are you interested in working on Data Mining and Analysis through systems sucha s LIMS and PAS-X? This role could be ideal for you. The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on: 1. Continued Process Verification (CPV. 2. Data Mining and Analysis. 3. Root Cause Analysis and Investigations. 4. Technical Report Writing. 5. Presenting CPV reports to regulatory agencies in audits. The Technical Operations Engineer is expected to continuously focus on safety, quality, GMP and operational discipline and will report to the Site CPV Lead. The Technical Operations Engineer is a member of the CPV team on site and is responsible for data mining and data analysis and investigation of out of trends in process data. He/she is also responsible for technical report writing and presentation of these reports to regulatory agencies in audits. The Technical Operations Engineer will : Own / lead or participate in the CPV program by issuing plans, protocols and reports and oversee the execution. Data mining through LIMS and PASX and statistical analysis of that data. Investigation of trends and discrepancies identified through CPV and resolution of same. Technical report writing for CPV reports. Closure of change controls, events and CAPA's on the Trackwise system. Presentation of CPV reports and finding to regulatory agencies. Assist in the preparation of annual product reviews (APR. The Technical Operations Engineer requires: University degree in Engineering or Science, Master Degree or Equivalent. A minimum of 1 year of experience in a pharmaceutical environment. Good working knowledge of Excel. Good level of statistical understanding. For more information please contact Eoin at LSC on 021-4777329 or apply direct through this invite. This job originally appeared on RecruitIreland.com.
2647 days ago