Biomedical Engineering Assistant jobs

The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is an MHRA Licenced Unit manufacturing a broad portfolio of terminally sterilised and non-sterile Specials (unlicensed) medicines. Additionally, under our MIA(IMP) License , the PMU provides clinical trial manufacturing activities through our collaboration with Kings Health Partners and other clinical trial organizations.

The PMU has an extensive portfolio of equipment and plant machinery to support pharmaceutical manufacturing activities, including processing & packaging lines as well as Water for Injection (WFI), Air Handling (AHU) and Autoclave systems.

The department is comprised of approx. 30 staff made up of operational teams, senior support and engineering teams.

The post holder will assist the PMU Engineering team in providing specialist engineering services to the PMU to ensure that all pharmaceutical manufacturing machinery and plant remains operational at all times. The key role responsibilities include:

• To carry out routine monitoring of the critical utility systems supporting pharmaceutical production and manufacturing process equipment.
• To perform routine maintenance, fault diagnosis and assist in the repair of critical utility systems and process equipment as agreed with the PMU Engineering and Maintenance Lead.
• To provide technical assistance for validation activities associated with the critical utility systems and processing equipment in conjunction with the Pharmaceutical Lifecycle Management team.
• To raise non compliances and support investigations into deviations in relation to engineering and equipment systems.

Guy’s and St Thomas’ NHS Foundation Trust is one of the largest and most respected NHS organisations in the UK, with a strong reputation for clinical excellence, research and innovation. The Trust is part of King’s Health Partners, an internationally recognised academic health sciences centre.

Within the Trust, Technical Services plays a vital role in supporting patient care through the manufacture and supply of high-quality unlicensed medicines and clinical trial products. The Pharmacy Manufacturing Unit (PMU) at Guy’s Hospital is a well-established facility operating to MHRA standards, offering a diverse and rewarding working environment with opportunities to develop expertise in pharmaceutical manufacturing, quality systems and clinical trials. The Engineering Team plays a vital role in ensuring that the facility and infrastructure of PMU is maintained to the highest safety and GMP standards.

Staff are supported through structured training, professional development opportunities and a collaborative team culture focused on safety, quality and continuous improvement.

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 process equipment 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 utility systems 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.