Job summary
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.
About us
?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 abrand-new, state-of-the-art Pharmacy Aseptic Unitat 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.
Job description
Job 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
Job description
Job 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
- 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
- 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
Desirable
- Hands on experience in pharmaceutical quality assurance and compliance, manufacturing and/or development, working with a broad range of pharmaceutical dosage forms
Skills
Essential
- 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
Person Specification
Qualifications
Essential
- 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
- 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
Desirable
- Hands on experience in pharmaceutical quality assurance and compliance, manufacturing and/or development, working with a broad range of pharmaceutical dosage forms
Skills
Essential
- 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
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.
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).
Additional information
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.
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).
