James Horne at CK Science is currently recruiting for a Validation Specialist. This is a unique position with a major initiative that has and continues to help develop the UK cell and gene therapy industry. Its vision has always been for the UK to be a global leader in the development, delivery and commercialisation of cell and gene therapies and a place where collaborating businesses can start, and confidently grow.
With custom built research and manufacturing faculties with more than 170 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. The overall aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.
The purpose of this role is to perform validation studies associated with the manufacturing centre, working across areas including; cleanrooms, laboratory analytical systems, medical gas supply and distribution systems and environmental monitoring systems. You will be responsible for authoring, executing and reporting validation activities within GMP framework.
Key responsibilities of this role include to:
- Support validation activities including contribution to the defining of validation requirements.
- Collaborate with validation contractors to support commissioning and start-up activities.
- Supervise validation testing performed by vendors to ensure work is complete and accurate.
- Be involved with in the implementation of a risk-based approach to the validation of systems in accordance with EU GMP guidelines.
- Assist in the writing of user requirement specifications, design/installation/operational and performance qualification protocols and reports for validation purposes.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Experience of validation in biopharmaceutical products or a combination of validation and engineering/commissioning experience.
- Experience of collaborating successfully with validation teams and a network of external contractors.
- Qualifications related to validation and quality compliance (HMP/ICH/FDA/USP guidelines/polices).
- Being a member of a recognised professional body is desirable.
For more information or to apply for this position please contact James on 0191 384 8905 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47406 in all correspondence.