Job summary
The Medical Interventions Group's clinical vaccine assessment activities are based at UKHSA Porton and occupy new world-class research facilities dedicated to the development and testing of new COVID-19 vaccines. Research undertaken includes clinical testing to support regulatory licensing of new COVID-19 vaccines and research to inform government decisions on vaccination policies.
Home to ground-breaking new technology vital to tackling both COVID-19 and a broad range of emerging health security threats, the facility houses new equipment which will improve the speed and capacity to evaluate COVID-19 vaccines and the potential risks from Variants of Concern.
The Research and Evaluation department based at UKHSA Porton Down has approximately 300 staff, performing a range of research activities, including high containment level work. The department's work covers a broad range of projects involving the development and evaluation of interventionsinto a range of infectious diseases e.g. monkeypox, SARS-CoV-2, TB, meningitis, anthrax and plague.
The department has also a test facility performing regulated studies in compliance with GLP, GCP and GMP.
Location
This role will be based at Porton Down, Salisbury
*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.*
Working Pattern -Full Time, Part Time, Job Share, Flexible Working,
Main duties of the job
Responsibilities section:
As the LIMS Technical Lead your main responsibilities will include:
The job holder will be required to carry out the following responsibilities, activities and duties:
- Taking a lead role in the project to implement and support the validation of a LIMS for a high throughput, regulated facility.
- Configuring Laboratory Information Management System (LIMS), validation rules, calculations, auto completions, implementing workflows, and overall support of LIMS.
- Ensuring that the LIMS is implemented and maintained in compliance with GCP regulations, with input from computer systems validation (CSV) and Quality Assurance (QA)
- Carrying out management and maintenance actions as recommended by the LIMS provider and Internal Standard Operating Procedures (SOPs) to maintain system integrity
- Working with software vendors to troubleshoot issues related to LIMS access or performance; maintaining and repairing LIMS to minimise downtime until solutions are reconciled. Maintaining communication with internal users and stakeholders to ensure appropriate decisions are made with regards business continuity
- Working with others to write documentation and manuals. Review LIMS SOPs and amend based on changes to functionality or in line with new developments or system upgrades
The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. Further duties/responsibilities can also be found on the full job description.
About us
The Medical Interventions Group's clinical vaccine assessment activities are based at UKHSA Porton and occupy new world-class research facilities dedicated to the development and testing of new COVID-19 vaccines. Research undertaken includes clinical testing to support regulatory licensing of new COVID-19 vaccines and research to inform government decisions on vaccination policies.
Home to ground-breaking new technology vital to tackling both COVID-19 and a broad range of emerging health security threats, the facility houses new equipment which will improve the speed and capacity to evaluate COVID-19 vaccines and the potential risks from Variants of Concern.
The Research and Evaluation department based at UKHSA Porton has approximately 300 staff, performing a range of research activities, including high containment level work. The department's work covers a broad range of projects involving the development and evaluation of interventionsinto a range of infectious diseases e.g. monkeypox, SARS-CoV-2, TB, meningitis, anthrax and plague.
The department has also a test facility performing regulated studies in compliance with GLP, GCP and GMP.
Job description
Job responsibilities
Key responsibilities:
- Assist the Senior Project Team Leader in the development, validation and maintenance of the LIMS and associated workflows for the different laboratory activities as required including some programming capabilities.
- Work with colleagues in computer systems validation (CSV) and Quality Assurance (QA) to ensure LIMS Is implemented and maintained in accordance with Good Clinical Practice (GCP)
- Liaise with UKHSA technology colleagues, management and local site administrators to ensure infrastructure and network is working appropriately and LIMS remains available to users.
- Carry out management and maintenance tasks as recommended by LIMS provider and Internal Standard Operating Procedures (SOP) to maintain system integrity.
- Validate, triage, manage and resolve issues reported by system users.
- Act as point of contact between external support organisations and internal support personnel ensuring appropriate action is taken to resolve issues in a timely fashion.
- Assist in laboratory IT support for the diverse instrumentation employed in the laboratories. Support the integration of such instrumentation with the LIMS
- Maintain communication with internal users and stakeholders to ensure appropriate decisions are made with regards to business continuity.
- Support the development and enhancement of LIMS systems and services, liaise with stakeholders to gather requirements, and work to develop and test enhancements and work alongside current support staff to train users as appropriate on new developments and enhancements.
- Lead members of the project team or project area to identify, evaluate and adapt new IT technologies, where appropriate, and to ensure that the project operates to a high standard using current methods.
- Collaborate and communicate with colleagues across LIMS team and wider Data Operations to share information, resources, and support. Seek feedback on the LIMS performance through communication with LIMS internal laboratory users; using feedback to improve performance.
- Assist with data provision, quality checking and cleansing, ensuring data is accurately and correctly reproduced between systems and processes for correct interpretation.
- Act as subject matter expert (SME) for LIMS during audits, ensuring the audit readiness of the following: qualification documentation, user lists and privileges, and procedures
- Apply the tools and techniques for data analysis, data visualisation and presentation working with the organisation's data architecture.
- Provide reports through collation of data using software and databases as necessary, to meet project targets and maintain productive, professional, and secure working environment.
- Take responsibility for the documentation of laboratory IT processes and procedures to comply with the requirements of Good Clinical Practice, review LIMS system documentation and standard operating procedures regularly and amending based on changes to functionality or in line with new developments or system upgrades.
- Assist in the supervision and training of staff, provide training on all aspects of the daily use of LIMS and associated IT laboratory systems as required.
- To perform any other duties required by the Line manager commensurate with grade.
- Attend UKHSA management meetings and report on the status of LIMS systems and services as required.
- Interpret and apply the organisations data and information security standards, policies, and procedures to data management activities, using knowledge of data protection and legal issues, and data life cycle.
- To ensure that undertakes work in accordance with UKHSAs Code of Safety Practice and to work within any Quality Systems that are applicable to the site.
- To maintain health and safety competence.
- To fulfil the requirements of UKHSA Values and Behaviours and the Civil Service Code.
- To comply with all UKHSA policies and procedures.
This vacancy is usingSuccess Profiles, and will assess your Behaviours/ Experience/Technical skills.
As part of the application process you will be asked to provide a Statement of Suitability in no more than 1250 words)
This should outline how you consider your skills, experience and achievements, provide evidence of your suitability for the role, with particular reference to the essential criteria outlined.
You will also be asked to provide information within the Employer/ Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history (this will be used in sifting process and will be scored).
Selection process details
STAGE 1 - APPLICATION & SIFT:
You will be required to complete an application form. This will be assessed in line with the advertised essential criteria please do provide evidence of how you meet this. You will also be asked to provide information within the Employer/ Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history.
Your Statement of Suitability should outline your skills, experience, and achievements, providing evidence of your suitability for the role, with reference to the essential criteria (outlined in the person specification section).
If you are successful at this stage, you will progress to an interview.
STAGE 2 INTERVIEW
This competition will involve an interview by video or face to face.
As part of the process, candidates will be invited to interview which will involve an in-depth discussion of your previous experience and professional competence in relation to the criteria set out in the Person Specification.
The Success Profiles framework will be used to assess and recruit the most suitable candidate. The following behaviours will be used at the interview:
- Working Together:Build strong interpersonal relationships and actively build a network of colleagues and contacts to achieve project progress. Remain available and approachable to all colleagues and be receptive to new ideas.
- Making Effective Decisions:Clarify your own understanding and stakeholder needs and expectations before making decisions. Analyse and accurately interpret data from various sources to support decisions. Confidently present reasonable conclusions from a wide range of complex and sometimes incomplete evidence.
- Managing a Quality Service:Proactively manage risks and identify solutions. Make clear, practical and manageable plans for service delivery, ensuring adherence to legal, regulatory and security requirements.
- Communicating and Influencing:Explain complex issues to a wide range of individuals in a way that is easy to understand. Experience of creating and giving presentations to a varied group of internal and external stakeholders, communicating in a clear, honest and enthusiastic way in order to build trust.
Technical Skills will also be assessed on:
- Experience of troubleshooting and problem solving software and hardware problems and providing support to colleagues
- Ability to communicate with a wide range of individuals and stakeholders for the purpose of project delivery
- Planning and prioritisation
For further information on the selection process, please refer to the attached Candidate Pack.
Expected Timeline:
Advert close:23:55hrs on 13th August 2023 unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Interviews:TBC
Please note these dates could be subject to change.
Job description
Job responsibilities
Key responsibilities:
- Assist the Senior Project Team Leader in the development, validation and maintenance of the LIMS and associated workflows for the different laboratory activities as required including some programming capabilities.
- Work with colleagues in computer systems validation (CSV) and Quality Assurance (QA) to ensure LIMS Is implemented and maintained in accordance with Good Clinical Practice (GCP)
- Liaise with UKHSA technology colleagues, management and local site administrators to ensure infrastructure and network is working appropriately and LIMS remains available to users.
- Carry out management and maintenance tasks as recommended by LIMS provider and Internal Standard Operating Procedures (SOP) to maintain system integrity.
- Validate, triage, manage and resolve issues reported by system users.
- Act as point of contact between external support organisations and internal support personnel ensuring appropriate action is taken to resolve issues in a timely fashion.
- Assist in laboratory IT support for the diverse instrumentation employed in the laboratories. Support the integration of such instrumentation with the LIMS
- Maintain communication with internal users and stakeholders to ensure appropriate decisions are made with regards to business continuity.
- Support the development and enhancement of LIMS systems and services, liaise with stakeholders to gather requirements, and work to develop and test enhancements and work alongside current support staff to train users as appropriate on new developments and enhancements.
- Lead members of the project team or project area to identify, evaluate and adapt new IT technologies, where appropriate, and to ensure that the project operates to a high standard using current methods.
- Collaborate and communicate with colleagues across LIMS team and wider Data Operations to share information, resources, and support. Seek feedback on the LIMS performance through communication with LIMS internal laboratory users; using feedback to improve performance.
- Assist with data provision, quality checking and cleansing, ensuring data is accurately and correctly reproduced between systems and processes for correct interpretation.
- Act as subject matter expert (SME) for LIMS during audits, ensuring the audit readiness of the following: qualification documentation, user lists and privileges, and procedures
- Apply the tools and techniques for data analysis, data visualisation and presentation working with the organisation's data architecture.
- Provide reports through collation of data using software and databases as necessary, to meet project targets and maintain productive, professional, and secure working environment.
- Take responsibility for the documentation of laboratory IT processes and procedures to comply with the requirements of Good Clinical Practice, review LIMS system documentation and standard operating procedures regularly and amending based on changes to functionality or in line with new developments or system upgrades.
- Assist in the supervision and training of staff, provide training on all aspects of the daily use of LIMS and associated IT laboratory systems as required.
- To perform any other duties required by the Line manager commensurate with grade.
- Attend UKHSA management meetings and report on the status of LIMS systems and services as required.
- Interpret and apply the organisations data and information security standards, policies, and procedures to data management activities, using knowledge of data protection and legal issues, and data life cycle.
- To ensure that undertakes work in accordance with UKHSAs Code of Safety Practice and to work within any Quality Systems that are applicable to the site.
- To maintain health and safety competence.
- To fulfil the requirements of UKHSA Values and Behaviours and the Civil Service Code.
- To comply with all UKHSA policies and procedures.
This vacancy is usingSuccess Profiles, and will assess your Behaviours/ Experience/Technical skills.
As part of the application process you will be asked to provide a Statement of Suitability in no more than 1250 words)
This should outline how you consider your skills, experience and achievements, provide evidence of your suitability for the role, with particular reference to the essential criteria outlined.
You will also be asked to provide information within the Employer/ Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history (this will be used in sifting process and will be scored).
Selection process details
STAGE 1 - APPLICATION & SIFT:
You will be required to complete an application form. This will be assessed in line with the advertised essential criteria please do provide evidence of how you meet this. You will also be asked to provide information within the Employer/ Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history.
Your Statement of Suitability should outline your skills, experience, and achievements, providing evidence of your suitability for the role, with reference to the essential criteria (outlined in the person specification section).
If you are successful at this stage, you will progress to an interview.
STAGE 2 INTERVIEW
This competition will involve an interview by video or face to face.
As part of the process, candidates will be invited to interview which will involve an in-depth discussion of your previous experience and professional competence in relation to the criteria set out in the Person Specification.
The Success Profiles framework will be used to assess and recruit the most suitable candidate. The following behaviours will be used at the interview:
- Working Together:Build strong interpersonal relationships and actively build a network of colleagues and contacts to achieve project progress. Remain available and approachable to all colleagues and be receptive to new ideas.
- Making Effective Decisions:Clarify your own understanding and stakeholder needs and expectations before making decisions. Analyse and accurately interpret data from various sources to support decisions. Confidently present reasonable conclusions from a wide range of complex and sometimes incomplete evidence.
- Managing a Quality Service:Proactively manage risks and identify solutions. Make clear, practical and manageable plans for service delivery, ensuring adherence to legal, regulatory and security requirements.
- Communicating and Influencing:Explain complex issues to a wide range of individuals in a way that is easy to understand. Experience of creating and giving presentations to a varied group of internal and external stakeholders, communicating in a clear, honest and enthusiastic way in order to build trust.
Technical Skills will also be assessed on:
- Experience of troubleshooting and problem solving software and hardware problems and providing support to colleagues
- Ability to communicate with a wide range of individuals and stakeholders for the purpose of project delivery
- Planning and prioritisation
For further information on the selection process, please refer to the attached Candidate Pack.
Expected Timeline:
Advert close:23:55hrs on 13th August 2023 unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Interviews:TBC
Please note these dates could be subject to change.
Person Specification
Education & Qualification
Essential
- Educated to degree level in Science subject or Information Technology; or equivalent level qualification / significant experience of working at a similar level in specialist area (formal qualification in IT is desirable)
- Significant working knowledge and experience of LIMS in a high throughput, regulated environment (e.g. GCP, ISO9001)
- Instrument integration experience
- Experience in troubleshooting software and hardware problems and triaging to relevant support colleagues as appropriate
- Problem solving skills, strategic thinking and the ability to respond to sudden unexpected demands
- Demonstrated capability to plan over short, medium and long-term timeframes and adjust plans and resource requirements accordingly
Person Specification
Education & Qualification
Essential
- Educated to degree level in Science subject or Information Technology; or equivalent level qualification / significant experience of working at a similar level in specialist area (formal qualification in IT is desirable)
- Significant working knowledge and experience of LIMS in a high throughput, regulated environment (e.g. GCP, ISO9001)
- Instrument integration experience
- Experience in troubleshooting software and hardware problems and triaging to relevant support colleagues as appropriate
- Problem solving skills, strategic thinking and the ability to respond to sudden unexpected demands
- Demonstrated capability to plan over short, medium and long-term timeframes and adjust plans and resource requirements accordingly
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.
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).
Additional information
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.
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).
