About this role
Job summary
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.
Main duties of the job
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:
o To carry out routine monitoring of the critical utility systems supporting pharmaceutical production and manufacturing process equipment.o To perform routine maintenance, fault diagnosis and assist in the repair of critical utility systems and process equipment as agreed with the PMUEngineering and Maintenance Lead.o To provide technical assistance for validation activities associated with the critical utility systems and processing equipment in conjunction with the Pharmaceutical Lifecycle Management team.o To raise non compliances and support investigations into deviations in relation to engineering and equipment systems.
About us
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.
Job description Job responsibilities
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.
Person Specification
Education/Qualifications Essential
A Level 3 Vocational Qualification in an engineering relevant subject or equivalent specialist experience, coupled with occupational training.
Previous Experience Essential
Portfolio demonstrating experience of working within a broad range of occupational guidelines
Desirable
Experience of working in a pharmaceutical manufacturing facility or similar GMP industry
Skills/Knowlede/Ability Essential
Demonstrated ability to clearly and accurately communicate complex technical information to a wide audience. Demonstrated ability to organise self to deliver engineering team priorities. Demonstrated ability to identify risk and carry out simple risk assessments with appropriate mitigation and escalation. Demonstrated ability to work in restricted areas such as clean rooms or plant rooms wearing appropriate PPE Demonstrated ability to comply with standard operating procedures and to assess other staff's compliance with these procedures.
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details Employer name Guy's and St Thomas' NHS Foundation Trust
Address Pharmacy Production, Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Employer's website https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)