Aseptic Programme Validation Engineer

Guy's and St Thomas' NHS Foundation Trust; London; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Aseptic Programme Validation Engineer to lead the validation processes for a state-of-the-art Pharmacy Aseptic Unit. This role offers a unique opportunity to influence the design and operational strategies of a facility dedicated to advanced therapies and chemotherapy preparation. The successful candidate will collaborate with various stakeholders, ensuring that all systems meet regulatory requirements and industry best practices. Join this innovative team and make a meaningful impact on patient care in a groundbreaking environment.

Benefits

Health Care Plans

Professional Development Opportunities

Flexible Working Hours

Employee Assistance Programs

Qualifications

• Expertise in validation processes and documentation.
• Experience with regulatory agencies like MHRA.

Responsibilities

• Lead validation activities for new aseptic unit design and operation.
• Ensure compliance with quality standards and regulations.

Skills

Validation Engineering

Regulatory Compliance

Quality Assurance

Cross-functional Collaboration

Education

Degree in Engineering or related field

Additional certifications in Quality Assurance

Tools

Validation Software

Quality Management Systems

Job description

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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.

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.

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.
  
  

For further details / informal visits contact: Name: Helen Callaby Job title: QP / Technical Lead Aseptic Unit Project Email address: [e-mail]

Paul Tunstell

Associate Chief Pharmacist

[e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care

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