About the job

Job summary

We are looking for a Computer Systems Validation engineer to join our Clinical Evaluation Team and contribute delivery of projects related to GxP testing of vaccine candidates in our Vaccine Development and Evaluation Centre (VDEC).

The VDEC is a world-class facility that conducts laboratory research to support all stages of vaccine and therapeutic development, from discovery to licensure on a range of emerging health security threats.

The Clinical Evaluation team in VDEC played a critical role in the COVID-19 response and is now expanding its scope and impact.

As a member of our team, you will help and shape the UK’s vaccine strategy and contribute to the health and economic prosperity of the nation.

This post will provide computer systems validation support to the Clinical Evaluation team which is part of the GxP test facility.

The post holder will be expected to have some experience in the validation of computerised systems for use regulated environments and will be required to have good general information technology skills and IT literacy.

Experience of working in a regulated environment and a proactive approach are desirable characteristics.

The post holder will be expected to engage with a wide variety of internal and external stakeholders including senior management, information technology, project sponsors, equipment vendors, auditors and regulators.

This post would suit someone looking to develop a career in computer systems validation and full training will be given.

Location

As this is a specialist role, it will be based and operate out of UKHSA Porton Down in Salisbury.

*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.* 

Job description

The job holder will be required to carry out the following responsibilities, activities and duties:

Supporting the Validation Team Leader in Computer Systems Validation projects within the Clinical Evaluation GxP Test Facilities in compliance with appropriate regulations including GCP, GLP and GMP.

1. Support the Validation Team Leader in the delivery of the full program of validation objectives to ensure all laboratory computerized systems run consistently in compliance with regulatory requirements
2. Liaise with a wide variety of stakeholders, e.g., system suppliers, laboratory users and managers, test facility management, information technology and validation to ensure to ensure appropriate validation support is delivered.
3. Manage validation projects and guide end users in the development and execution of appropriate test documentation.
4. Review executed validation documentation and author validation summary reports.
5. Analyse and interpret validation and laboratory systems data and provide written reports to Validation, Quality and Test facility management in line with overall responsibilities.
6. Provide oral and written reports and presentations on validation activities to Senior Management (Quality and Test Facility) in line with overall responsibilities.
7. Provide support during reviews and customer audits and regulatory inspections and work with validation lead to plan and implement any improvement actions.
8. Contribute to and attend internal and external audits and regulatory inspections as required. Contribute to the review and closure of audit non-conformances, CAPA reports and related investigations.
9. Undertake reviews of documentation, studies (including critical phases and data packages), GxP laboratories, supporting areas and critical suppliers of services and material as directed
10. Liaise with equipment and systems providers to develop user requirements, evaluate and test solutions to ensure regulatory compliance.
11. Undertake relevant training and perform other duties as required by the Line manager
12. Fulfil the requirements of UKHSA Values and Behaviours commensurate with grade
13. Comply with all UKHSA policies and procedures

The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. The Job holder is expected to accept reasonable alterations and additional tasks of a similar level that may be necessary.

Person specification

It is important through your application and Statement of Suitability of 1250 words that you give evidence and examples of proven experience of each of the essential criteria (for full details of all essential criteria please refer to the attached job description) and the following criteria below:

The behaviours:

• Working Together – Lead criteria when sifting
• Delivering at pace
• Communicating and Influencing

Technical Skills:

• Knowledge and Experience of Computer Validation systems and ICT proficiency.
• Knowledge and Experience of having worked within and/or supported GMP, GLP or GCP regulated test facilities.
• Knowledge and Experience of validation, preferably in lab environment

Essential

• Educated to HNC/D level or above in a relevant subject or equivalent level of experience of working at a similar level in specialist area
• Knowledge and demonstratable practical experience in validation and qualification of laboratory equipment software in a regulated environment (i.e., in a pharmaceutical environment). 
• Knowledge and experience of generating computer system validation reports and documentation.
• Experience in liaising with laboratory systems users to plan/deliver work and with auditors and regulators to implement quality actions.
• Independent thinker with demonstrated problem-solving skills, able to use technical knowledge to pre-empt and evaluate issues and recommend a range of options and actions to a wide range of stakeholders to address these issues.
• Adaptability, flexibility and ability to cope with uncertainty and change
• Meticulous attention to detail to identify issues and to ensure they are resolved

Desirable

• Knowledge and experience in the validation and qualification of laboratory equipment and control systems e.g., building monitoring systems, temperature mapping systems, microwell plate readers, high-definition image scanners
• Experience in developing and adapting laboratory equipment operating protocols and software to meet regulatory requirements
• Good understanding and experience of safe working practices in a laboratory facility

Benefits

Working for the UKHSA

For more information on the UKHSA please visit: UK Health Security Agency - GOV.UK (www.gov.uk)

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension with an average employer contribution of 27%
• Range of health and wellbeing support

Any move to UKHSA 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 at Childcare Choices , 30 Hours Free Childcare, Tax-Free Childcare and More , Help with Costs , GOV.UK

Things you need to know

Selection process details

STAGE 1 - APPLICATION & SIFT: 

You will be required to complete an application form. This will be assessed in line with the full list of essential criteria as detailed in the attached job description – please do provide evidence of how you meet this. 

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 and behaviours stated (outlined in the person specification section).

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.

These will both be used in the sifting process and will be scored.

If you are successful at this stage, you will progress to an interview.

STAGE 2 – INTERVIEW 

This competition will involve an interview by either Teams or in person.

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
• Delivering at pace
• Communicating and Influencing

For further information on the selection process, please refer to the attached Candidate Pack.

Expected Timeline:

Advert close: 23:55hrs on 16th July 2024 – 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.  

Security clearance level requirement

Successful candidates must pass a disclosure and barring security check.  Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Basic Personnel Security Standard.  People working with government assets must complete Basic Personnel Security Standard checks.

For posts on UKHSA Civil Service terms and conditions, new entrants to the Civil Service are expected to start on the minimum of the pay band. For existing Civil Servants and roles advertised across government, the rules of transfer apply, i.e., level transfers move on current salary or the pay range minimum, transfers on promotion move to new pay range minimum or receive a 10% increase. Either case is determined by whichever is the highest. 

Please Note

This role is to be appointed under Civil Service Terms & Conditions. Full details on the T&C’s are found https://www.ukhsa.reed.com/

Are you already a civil servant, or employed by a Civil Service Commission accredited public body? Please state home department on your application form.

Do you meet the nationality requirements for this post? https://www.ukhsa.reed.com/

Complaint process:

The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission's Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email: Complaints1@ukhsa.gov.uk. If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website. 

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

Please note this Post is NOT regulated by the Civil Service Commission. The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.