Validation Engineer

£39,912 - £48,635

Permanent, 37 hours per week

Location: Edinburgh

About the Organisation:

National Services Scotland (NSS) is a national NHS Board operating right at the heart of NHSScotland providing invaluable support and advice at a strategic and operational level. NSS supports customers to deliver their services more efficiently and effectively and we offer shared services on a national scale using best-in-class systems and standards. Our priority is always the same – to improve the health and well-being of the people of Scotland. We do this by working in partnership with colleagues across Health and Social Care to deliver fit for purpose solutions and systems, delivering high quality services that help our stakeholders to free up resources so they can be re-invested into essential services.

The Post:

The core purpose of the Scottish National Blood Transfusion Service is to meet the transfusion needs of patients in Scotland. In support of this, we are committed to a range of programmes that will enhance the service provided to NHS Scotland in both clinical and operational areas.

Expected to work in collaboration with Validation Manager, Senior Validation Engineer, other Validation Engineer and Subject Matter Experts to ensure a harmonised approach in line with policies and procedures.

The candidate would be a member of the MVS (Maintenance and Validation Services) Team, specialising in the provision of validation services and support across all SNBTS locations (e.g. Glasgow, Edinburgh, Dundee, Aberdeen and Inverness) to all directives of the organisation including Donor Services, Testing, Transport, TCAT, NMRU, Processing, Patient Services and Procurement. The post holder will provide support and leadership to ensure compliance with both software and hardware validation regulatory requirements and additionally provide validation support, resource, guidance and expertise to projects on validation requirements, including the development of validation plans, preparation and execution protocols and authoring of reports.

The primary function of the role is to assist in the provision of a temperature mapping service, mapping controlled temperature environments (including, but not limited to: fridges, freezers, incubators and rooms) at temperatures ranging from -196°C to 40°C.

The post holder will report directly to the Senior Validation Engineer supporting them in the delivery of SNBTS projects/plans. The is also an expectancy that the post holder will frequently travel to the NHS centres at the locations noted above in support of this role.

The Candidate:

Applications are invited from professionals who have experience in the operations of Quality Management system in a life science, medical device, pharmaceutical or similar environment. Educated to Honours degree level or equivalent potentially holding a postgraduate professional qualification eg. MSC. You will be required to work with a degree of autonomy and will be highly motivated with strong analytical and problem solving skills, including presentation of results in reports. You will have excellent communication and interpersonal skills and will be adept at communicating with a wide variety of people on many different levels.

This post requires a high level of concentration and you will provide hands-on support in the delivery of local and national validation projects, change management and CAPA processes across SNBTS. Proven experience in Six Sigma, Lean methodologies and project management would be an advantage with the successful applicant being required to show evidence of being a team member in an effective workforce.

An awareness and understanding of GMP, Validation Lifecycle, and experience/knowledge in the following would be advantageous:

1. Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide).

2. EudraLex Volume 4 GMP Annex 15: Qualification & Validation.

3. Blood Safety and Quality Regulations (BSQR) 2005 (amended).

4. Transfusion Guidelines (JPAC, the Red Book).

5. ISO 13485, 9001 or equivalent.

6. Computerised Systems Validation using GAMP 5.

7. MHRA, HTA regulatory bodies.

8. Six Sigma, Lean Manufacturing

9. Project Management

Location and Working Pattern:

The post will be based at the SNBTS Headquarters at the Jack Copland Centre, Edinburgh.

Travel to other locations will be required on a regular basis. Travel can be via public transport, SNBTS pool car or using your own car.

Currently hybrid working.

The work pattern is Monday to Friday, 37 hours per week.

It is a condition of this employment that you must live and remain a resident within the UK for the post in which you will be employed with NSS.

Benefits:

Our benefits package includes pension scheme, comprehensive range of work life balance policies, occupational health services, learning resource centres and discounted leisure, financial and shopping benefits. HR Benefits Brochure.

Inclusion:

NHS National Services Scotland (NSS) is a national board and, as an anchor institution, it is our ambition to be a diverse and inclusive organisation where everyone feels welcome. We recognise that flexible working creates an inclusive workplace where employees can thrive and feel confident about their ability to balance their personal and professional responsibilities. This is supported through Once for Scotland flexible working policies. NSS has made a long-term commitment to staff health and well-being and offers many learning and development opportunities to support and improve our approaches to diversity, inclusion and mental health in the workplace. There are a number of equality staff networks in place which all staff are welcome to join. We are also an equal opportunities employer and as such guarantee to interview all disabled applicants who meet the minimum criteria for our vacancies. As an accredited Disability Confident Leader, it is the aim of NSS to offer a fully accessible and inclusive recruitment service that supports applicants on their candidate journey. If you are interested in any reasonable adjustments, please contact the Recruitment Team.

Further information:

For an informal discussion on the post, please contact Sam Nicholson, Validation Manager

Closing date for completed applications is 21 February 2025.

To apply please click the Apply Button

Further information on NSS is available from our website

Please note that the majority of correspondence is sent by e-mail only, so please check your e-mail regularly (including junk folders).