Role Overview & Mandate
Executive Summary
We are currently looking for two Manufacturing Coordinator to join our (adjective) Standards Lifecycle Team within the...
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Sources: USCIS E-Verify & Home Office CoS
We are currently looking for two Manufacturing Coordinator to join our (adjective) Standards Lifecycle Team within the Science, Research, and Innovation Group.
These are two full-time opportunities, one on a permanent basis and one on a 12-month fixed term contract/internal move or temporary promotion basis. The role will be based in South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
Who are we?
The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
The Scientific Research and Innovation Group (SR&I) delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.
The Markey Analysis, Manufacturing, and Logistics function (MML) is responsible for the processing, freeze drying, storage and distribution of biological standards. The Manufacturing Department fills, freeze dries, labels these standards working closely with the other MML functions to ensure global supply needs are met.
What’s the role?
The post holder will organise and provide a range of services including the preparation, filling, freeze drying, sealing, quality control testing and labelling of biological reference materials including WHO reference materials, pandemic materials and influenza products associated with timely responses to global public health requirements, in accordance with quality standards
Key responsibilities:
- Accurately process biological materials using several different manufacturing lines, including the preparation and sterilisation of equipment and components, operation of complex filling machinery and freeze dryers, labelling and packing of products ensuring correct information for biological and chemical hazards is included to meet legislative demands, and storage at correct conditions.
- Carry out sampling and quality control testing on all biological materials processed including complex analytical methods for determining the residual moisture content and oxygen concentration in the headspace of the container.
- Accurately prepare and complete detailed relevant documentation to meet quality system demands such as manufacturing records, records of deviations and / or anomalies, corrective / preventative actions, quality control testing results, freeze drying documentation, decontamination certificates, correspondence from scientific staff to support manufacturing methods used.
- Maintain the cleanliness of the manufacturing environment according to recognised clean room standards with regular cleaning of walls, floors and manufacturing machinery including using a rotation of disinfectants and fumigation procedures after infectious procedures.
Who are we looking for?
Our successful candidate will:
- Experience of working in a Pharmaceutical Manufacturing or Laboratory environment. This role may also suit a recent graduate in a relevant subject such as Microbiology or Biotechnology and an interest in Manufacturing.
- Working within a quality management system such as GMP, GLP or ISO 9001
- Team working experience
- PC competent – Microsoft office skills, ability to learn software for bespoke applications.
- Good communication skills.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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The selection process:
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles and a statement of suitability, attached as a PDF how you meet the person specification (Experience and Behaviours). Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. Please ensure not to include any personal identifying information on your supporting information.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers and the statement of suitability provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.
If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.
Closing date: 10/03/2023
Interview date: 22-24/03/2023
If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.
Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.
Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.
Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.
In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk.
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
info@csc.gov.uk
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