About the job

Job summary

The Vaccine Development and Evaluation Centre’s GXP Test Facility is based at UKHSA Porton and supports new world-class research facilities dedicated to the development and testing of vaccines against COVID-19 and other emerging / pandemic threats. 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 GXP Test Facility at VDEC is part of the Research and Evaluation department. The department 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 interventions into a range of infectious diseases e.g., SARS-CoV-2, TB, meningitis, anthrax, and plague. 

As the Computer Systems Validation Project Manager, you will lead the validation effort supporting the implementation of computer systems identified as critical to GxP compliant operations within the Vaccine Development and Evaluation centre (SAAS EQMS & SAAS LIMS). You will work with vendor implementation and UKHSA application project teams to deliver a project validation package documenting the validation activities supporting each implementation and providing documentary evidence confirming that the system is validated for use in a GxP regulated environment. 

You will develop appropriate validation control documentation (e.g., VMP, VSR, TM, RA) and guide end user representatives in the development and execution of appropriate test protocols (IQ/OQ/PQ).  Where third party validation partners are engaged, you will oversee their activity, review, and approve documentation, conduct gap analyses to identify additional test requirements and incorporate documentation into the project validation document set. You will also co-ordinate the activities of vendor implementation teams, 3rd party validation partners and UKHSA project team members to ensure delivery of a validated solution.

Location

This role will be located at UKHSA Porton Down, SP4 0JG.

*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

Job description

As the Computer Systems Validation Project Manager, the post holder will be responsible for:

• Overall management responsibility for computer system validation project delivery for specific projects supporting GxP regulated operations within the Vaccine Development and Evaluation centre.
• Providing leadership, communication, and expertise in aspects of Computer System Validation to the project team, with a particular focus on GXP compliance and data integrity.
• Interacting with the laboratory scientists and technicians, the quality assurance team, the leadership team, and a range of stakeholders both externally and from elsewhere in UKHSA as these projects develop and proceed to effective delivery.
• Acting as the point person for ensuring that compliant solutions are delivered using the most relevant and appropriate validation management tools.
• Playing a key role in the future operating status of the Vaccine Development and Evaluation Centre and will support the identification and evaluation of vaccine candidates for emerging diseases of concern.

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.

Please see the job description for the full list of duties and responsibilities.

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 following criteria: 

Essential

• Educated to Post graduate degree level in appropriate discipline with considerable experience (or equivalent)
• Evidence of specialist training / experience in specific methods required for the post including equipment and computer systems validation
• Extensive practical, pharmaceutical industry experience of facilities, equipment, GxP Critical Utilities operation, and current validation technologies
• Specialist experience of application of computer systems validation to support GxP projects
• Experience as an SME of FDA / MHRA Regulatory inspections
• Ability to provide and receive highly complex, sensitive or contentious information, negotiate with a range of stakeholders on difficult and controversial issues, manage stakeholder expectations and present complex and sensitive information to large and influential groups
• Problem solving skills and ability to respond to sudden unexpected demands
• Ability to analyse complex facts and situations and develop a range of options
• Ability to make decisions autonomously, when required, on difficult issues, working to tight and often changing timescales and where there may be a number of courses of action
• Meticulous attention to detail to identify data/study issues and ensure these are resolved and any lessons learned are identified and actioned

Desirable

• Experience in line management, performance management, recruitment, training and/or mentoring.

Benefits

• 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%

Things you need to know

Selection process details

Stage 1 – Application and sift: 

You will be required to complete an application form and a statement of suitability. This will be assessed in line with the advertised essential criteria – please do provide evidence of how you meet this. 

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

Stage 2 – Interview

This competition will involve an interview either 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. 

Please be aware that you may be asked to undertake a test or presentation at interview.

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).

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.

The Success Profiles framework will be used to assess and recruit the most suitable candidate.  The following behaviours will be used at the interview:

• Making Effective Decisions
• Working Together
• Managing a Quality Service
• Delivering at Pace

Expected Timeline:

Advert close: 23:55hrs on 7th January 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.

Shortlist: TBC

Interviews: w/c 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

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window). 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.