CSV Specialist

Blackfield Associates are currently partnered with a Cell and Gene Therapy organisation in their search to find a CSV Specialist to join their team at their facility based in Cambridgeshire.

This role will primarily focus on validating the onboarding of new computerised systems to meet the needs of a rapidly growing customer base, as well as supporting the ongoing validation of expanding software systems. The position involves close collaboration with IT to establish data integrity requirements and evaluate the effectiveness of implemented solutions.

Responsibilities:

• Support the implementation of a risk-based approach to the validation of computerised systems to ensure compliance with Annex 11, 15 and GAMP 5.
• Preparing and execution of protocols for configuration, functional, end-to-end and user acceptance testing.
• Preparing and maintaining validation plans, assisting system owners with impact assessments, risk assessments and identifying validation requirements for computerised systems projects.
• Assist in the authoring of User Requirement Specifications.

Experience:

• Sufficient prior experience of validating computer systems in a Biopharmaceutical setting.
• A Degree (or equivalent experience) in a Science or related discipline.
• Experience in the validation of GxP software and Laboratory systems.
• Prior ERP integration experience would be advantageous, but not essential.