Equipment Validation Officer

Job description

Job responsibilities

1. Support the Validation team Senior Engineer and Team Leader to deliver the Validation Function objectives for laboratories performing regulatory clinical studies i.e. laboratory equipment qualification, planned testing and validation.
2. To liaise with laboratory managers, laboratory staff and suppliers to ensure validation activities are completed.
3. Collate and analyze validation and laboratory systems data and contribute written reports to Validation, Quality and Test facility management.
4. Contribute to internal and external audits and regulatory inspections where required.
5. To assist in the review and closure of audit, non-conformances and CAPA reports and related investigations
6. To liaise with external suppliers and customers where required.
7. To assist with the review and closure of audit, non-conformances and CAPA reports and related investigations
8. To undertake relevant training. To perform any other duties required by the Line manager.
9. To ensure that the project team undertakes work in accordance with the UKHSAs Code of Safety Practice and to work within any Quality Systems that are applicable to the site
10. To maintain health and safety competence to the national occupational standard Make sure your actions reduce risks to health and safety (NOS HSS1)

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 job description attached for full list of duties and responsibilities

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.

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

STAGE 2 INTERVIEW

This competition will involve an in-person interview

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.

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 and technical skills will be used at the interview:

• Communicating and Influencing
• Working Together
• Delivering at Pace

Technical Skills will also be assessed on:

• Knowledge and experience of laboratory equipment qualification and validation.
• Knowledge and Experience of having worked within and/or supported GMP, GLP or GCP regulated test facilities.
• Able to work flexibly with team and lab users to deliver project objectives

Expected Timeline:

Advert close: 23:55hrs on 4th September 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.

Shortlist: 8th September 2023

Interviews: w/c 18th September 2023

Please note these dates could be subject to change.

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants)

Nationality requirements

Appointments to roles within UKHSA will be made in accordance with the Civil Service nationality rules. These can be found athttps://www.gov.uk/government/publications/nationality-rulesThis job is broadly open to the following groups:

• UK nationals
• Nationals of Commonwealth countries who have the right to work in the UK
• Nationals of the Republic of Ireland
• Nationals from the EU, EEA or Switzerland with settled or pre-settled status or who apply for either status by the deadline of theEuropean Union Settlement Scheme (EUSS)
• Relevant EU, EEA, Swiss or Turkish nationals working in the Civil Service
• Relevant EU, EEA, Swiss or Turkish nationals who have built up the right to work in the Civil Service
• Certain family members of the relevant EU, EEA, Swiss or Turkish nationals

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's Recruitment Principles.

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.

The Civil Service welcomes applications from people who have recently left prison or have an unspent conviction. Read more about prison leaver recruitment.

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

Essential

Essential

• Educated to HNC/D level in a relevant subject or equivalent level of experience of working at a similar level in specialist area
• Knowledge and experience of laboratory equipment and control systems e.g. asset systems, building monitoring systems, temperature mapping systems.
• Knowledge and experience in laboratory equipment qualification and validation
• Knowledge and Experience of having worked within and/or supported GMP, GLP or GCP regulated test facilities.
• Good understanding and experience of safe working practices in a laboratory facility.

Desirable

• Experience and knowledge of equipment validation reports and documentation.

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

Porton Down

SP4 0JG

Employer's website

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