Computer Systems Validation Project Manager

Job description

Job responsibilities

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.

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&Cs 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.

Person Specification

Qualifications

Essential

• Educated to Post graduate degree level in appropriate discipline with considerable experience (or equivalent)

Experience

Essential

• 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

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

UK Health Security Agency

Address

UKHSA Porton Down

Salisbury

SP4 0JG

Employer's website

https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)