Technical Operations Specialist

Pe Global

Cork

PE Global is currently recruiting for a Technical Operations Engineer/Scientist for a Client site in Cork: 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. The Technical Operations Engineer / Scientist will report solid line 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. Principal Responsibilities: 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. Requirements: Specific Systems: Good working knowledge of Excel. Good level of statistical understanding, Minitab, Trackwise, Docspace. Education: University degree in Engineering or Science, Master Degree or Equivalent. A minimum of 1 year of experience in a pharmaceutical environment. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2644 days ago