Computer Systems Validation Contractor

Key Details

Description

CGT Catapult has entered into a strategic collaboration agreement with Ena Biologics for the development and manufacture of biologics. This collaboration for the Braintree site requires significant qualification and validation of systems, equipment, and processes. The objective of this collaboration is to launch a commercial GLP-1 Biosimilar into the European market in 2029. Commercial medicinal products require full end to end qualification and validation of all direct impact systems, equipment, and processes ensuring documented and objective evidence that they meet their intended use and ensure all critical process parameters and critical quality attributes are documented and validated. To enable the success of this collaboration a significant body of work is required from the CGT Catapult validation team in qualifying and validating various items of CGT equipment. This requires a CSV contractor on a 6 months contract to support CGT Catapult in the initiation of the Ena project by supporting with the qualification and validation of various items of key project equipment. The post will be for an onsite position at our Braintree site: 4 Warner Dr, Springwood Industrial Estate, Braintree CM7 2YW