Validation Engineer

As a vital part of NHS Scotland, NHS National Services Scotland's mission is to enable and support the delivery of better health and better care, working in partnership. We do this by providing a range of specialised support services that enable NHS Boards to focus their efforts on delivering health improvement and patient care. As a major division within the NHS National Services Scotland, the Scottish National Blood Transfusion Service (SNBTS) plays a vital role, not only in the health of the people of Scotland but also on an international scale through our leading position in new product development biomedical research and donor/clinical services. Our goal is to maintain the highest standards of donor and patient care whilst remaining internationally competitive.

Educated to, or operating at, Degree level with evidence of other continued professional development, you will have a proven track record of working on validation and qualification projects and activities,

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

Mapping of controlled temperature environments (inclusive of fridges, freezers, incubators and rooms) at temperatures ranging from -196°C to 40°C across multiple SNBTS locations within Scotland on a regular basis with travel to sites a regular requirement. 

Experience working in a GMP environment, with oversight and a lead role in the design, execution and reporting of validation projects.

Specifically, this includes proven experience/knowledge in the following:

• Working within the guidelines/regulations in at least some of the:

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. SO 13485, 9001 or equivalents.

• Understanding the validation lifecycle (in a GMP organisation).
• Development of the validation strategy and rationale for validation projects using a risk-based approach.
• Equipment Qualification, Method Validation and Process Validation.
• Computerised Systems Validation using GAMP 5.
• Writing and execution of validation protocols and reports (VP, URS, DQ, IQ, OQ, PQ, PV, MV, UAT and VSR).
• Line Management Experience.
• Liaising with the cross functional team to ensure plans, protocols and reports meet expectations and requirements and are executed/delivered in line with the business needs of the organisation.
• Development of test methods used to verify product and process performance, ensuring acceptance criteria and sampling plans meet statistical and robustness needs of the organisation.
• Risk Assessments, Incident Management and Change Control.
• Quality Management Systems.
• Ensuring GxP standards are maintained at all times.

You will be required to work with a degree of autonomy and will be highly motivated with strong problem solving skills.  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 and change management processes across SNBTS. You will be required to undergo a PVG Scheme Disclosure Scotland check.

Any candidate who has lived/worked overseas for more than 12 months in the preceding five years will also be required to provide a criminal record check from the appropriate overseas agency.

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.

For an informal discussion on the post, please contact Sam Nicholson, National Validation Manager on 07964840319.
Further information on NSS is available from: https://www.nss.nhs.scot/
Closing date for completed applications is 26th January 2022 
Please note that the majority of correspondence is sent by email only, so please check your email regularly (including junk folders).

NHS National Services Scotland is an equal opportunities employer and as committed participant in the disability confident scheme, guarantees to interview all disabled applicants who meet the minimum criteria for our vacancies