Validation Specialist

Validation Specialist

Job Title: Validation Specialist
Contract Type: Permanent
Location: Stevenage
Salary: £40000 - £45000 per annum, Benefits: plus bonus, pension, life insurance, health insurance and other flexible benefits
Start Date: 2020-01-13
Reference: V-46031
Contact Name: James Hume
Contact Email:
Job Published: January 13, 2020 15:45

Job Description

A cutting-edge biotech based in Stevenage are recruiting for a Validation Specialist to work across their manufacturing centre in compliance to GMP, working on a range of projects at any one time to ensure validation objectives are delivered in a timely manner. The company are a leading the way in the commercialisation of life changing therapies, taking these through the commercialisation process using their expertise and cutting-edge services. 

The role of Validation Specialist is to be part of the ream responsible for related activities in this state-of-the-art facility for their equipment, facilities, utilities and laboratory systems.  This site is currently expanding with new clean rooms that have been built and currently being validated for use by collaborators, and once this has been completed you will responsible for the ongoing validation activities.  You will be working on multiple projects at a time, working in close partnership with collaborators throughout the project lifecycle.  

A key part of this role will be the authoring, executing, and reporting of activities in compliance to GMP, annex 11 & 15 and their QMS requirements.  As the Validation Specialist you will provide input into defining requirements for activities to keep compliance e.g. Annex 11 & 15 or GAMP and what is required to deliver projects.  You will undertake DQ / IQ / OQ / and PQ as well as support the writing of user requirement specifications, and other relevant protocols such as design or installation qualification for example.  You will be involved in the risk-based approach to the validation of systems on compliance to GMP annex 11, 15, US FDA, and GAMP 5 guidelines.  As the Specialist you will work contractors to support commissioning and start up activities, to then maintain systems once production operations have been set up.  

Desired Skills and Experience:  You will need to have validation experience in Biopharmaceutical / Biologics or related environment with a combination of validation, engineering / commissioning experience.        You will need to have experience of GMP with an understanding of relevant regulations such as Annex 11 & 15 and GAMP 5.  As this is an automated environment you will need experience of related systems, alongside process instrumentation, utility systems, and analytical equipment. Membership of a professional body is advantageous to your application but not essential. 

The Company: The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry.  Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market.  They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialization of these fast developing, cutting edge technologies.  They have constructed a purpose-built manufacturing centre which opened at the end of 2017 and immediately after opening additional funding was allocated for the centre to be doubled in size due to the demand for their services.  This currently consists of 12 (of which 6 very recently completed) clean room suites out for collaborators to use to manufacture advanced therapies for use in clinical trials.