Aseptic Programme Validation Engineer
Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.
Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary’s Hospital in Sidcup.St Thomas’ has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children’s Hospital.
Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it.Our community services include health visiting, school nursing and support for families of children with long-term conditions.
Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.
In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.
We have a reputation for clinical excellence and high quality teaching and research. We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.
Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’.Our adult community services achieved a rating of ‘outstanding’.
The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS.We know this has a positive impact on the care provided to our patients.
We have one of the most ambitious capital investment programmes anywhere in the NHS.
Job overview
An exceptional opportunity has arisen to provide engineering and validation expertise and leadership for the design, build and validation of a purpose built Paediatric Cancer and ATMP facility due to open at St Thomas’ Hospital in September 2026.Once the new unit is opened, the post holder will provide engineering and validation support to all the aseptic units working cross site and collaborating with Pharmacy, Trust engineering, suppliers and contractors.
Main duties of the job
The Aseptic Project validation engineer is overall responsible for ensuring equipment is suitable for its intended use through the development and execution of qualification documentation to support the System Life Cycle, including facilities, utilities, equipment, and automation.
The Aseptic Project Validation Engineer is responsible for interaction with regulatory agencies (MHRA and regional QA), certifying bodies, management, and critical customers.
The role of Aseptic Project Validation Engineer is varied providing multiple opportunities to influence strategy and direction in the realm of validation and sterility assurance. It is also a role dependant on functional expertise where the successful candidate will become a both a voice and arbiter for equipment quality standards across a diverse portfolio of products within the NHS Guy’s and St Thomas’ hospital production units.
Reporting to the Project Lead for the duration of the programme, you will lead in planning and managing resources so that validation activities and associated documentation are completed in accordance with schedules and meet regulatory requirements.
Review validation practices and processes in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements.
Working for our organisation- Join Us at the Forefront of Innovation in Cancer & Advanced Therapy Care!
Pharmacy Aseptic Services – Guy’s & St Thomas’ NHS Foundation Trust
We’re embarking on a groundbreaking journey—and we want you to be a part of it.
Guy’s & St Thomas’ is building a brand-new, state-of-the-art Pharmacy Aseptic Unit at our St Thomas’ site, purpose-built for the preparation of chemotherapy and cutting-edge advanced therapies. This is more than just a project—it’s a transformation that will shape the future of patient care.
- Why Join Us?
- Be at the centre of innovation: Play a vital role in designing and launching a modern aseptic facility.
- Drive real impact: Your expertise will directly contribute to improving outcomes for patients requiring highly specialised treatments.
- Work with the best: Collaborate with leaders across pharmacy, clinical services, procurement, finance, and Trust management.
- Shape the future: Influence every stage—from specification and validation to full operational delivery—with quality and patient care at the heart of it all.
- What You’ll Be Doing:
- Leading on technical aspects of the new unit’s design and operation.
- Ensuring full compliance with regulatory and quality standards.
- Being a key voice in a cross-functional project team to create a facility that is future-ready.
- Helping to deliver a unit that reflects the evolving needs of modern medicine.
Detailed job description and main responsibilities
Main areas of the role relate to:
Project phase
Retirement phase
Documentation control
Team work
Audit response
See detailed duties in the job description
Person specification
Qualifications
Essential criteria- Batchelor of Science degree in maths, engineering, computer science or related scientific discipline or extensive experience to equivalent level working in a pharmaceutical validation role
Experience
Essential criteria- Experience of working with pharmaceutical isolators for aseptic processing with gassing capability
- Specific quality and compliance expertise in sterile dose forms and functional expertise in pharmaceutical equipment and process validation
- Previous experience of managing service level agreements / quality technical agreements with external service providers
- Hands on experience in pharmaceutical quality assurance and compliance, manufacturing and/or development, working with a broad range of pharmaceutical dosage forms
Skills
Essential criteria- Demonstrated ability to manage commissioning and qualification activities for pharmaceutical equipment and systems
- Demonstrated ability to manage deviations, non compliances, change control & CAPA as well as perform risk assessments & root cause analysis
- Demonstrated understanding of validation of equipment & processes and ability to write validation documentation and ensuring validation plans are adhered to
- Demonstrated ability to critically review GMP documentation including validation protocols / unit/equipment plans and standard operating procedures completed or created by others
- Demonstrated ability to prioritise own workload, coordinate multiple concurrent activities and that of others and to manage own time effectively
Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.
Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.
Flexible working
We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual’s personal circumstances as well the needs of the service.We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.
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