PMU Engineering Assistant

The following are the main responsibilities of the role (see attached

Job Description)

Technical / Operational To monitor the performance of the PMU critical utility systems and processequipment by carrying out routine field checks in addition to entering, analysing and reporting the data using spreadsheet software. To assist in the maintenance and operational efficiency of the critical utilitysystems and process equipment within the PMU. This includes the Water for Injection production and distribution system plus supporting utilities, the Air Handling Units and Autoclave. To diagnose and detect faults on utility systems and production equipment, communicating any findings to the appropriate seniors and recording faults on machine and system logs. Calibration and Validation To perform routine preventative maintenance on critical utility systems and process equipment. To carry out calibration activities on PMU processing equipment in accordance with current GMP guidelines, Regulatory and ISO standards, ISPE guidance after relevant training. To carry out routine validation of critical systems within the manufacturing facility, after relevant training Quality Management To maintain logs and documentation in accordance with current guidelines and regulatory requirements. To raise non-conformances and assist with deviation investigations on the Pharmaceutical Quality System. To manage and maintain the engineering documentation folders ensuring all completed documentation is correctly scanned, filed and stored accurately to aid easy retrieval. Training / Education / Professional Development To assist with induction of new and rotational staff with regards to operational awareness of engineering systems and processing equipment. Undertake training as and when required to obtain, maintain and develop skills and knowledge base. Be able to learn and adapt to new techniques, embrace training and provide written and verbal instruction to staff and colleagues on all aspects or their work.