Interim Validation Engineer
Our Client is establishing a new Manufacturing Operations group that is responsible for the technology transfer and manufacturing of its pioneering immunotherapy products. Their GMP manufacturing operation is based within the Catapult Cell and Gene Therapy (CGT) Manufacturing Centre in Stevenage.
We are seeking a Technical Operations Support Associate to lead the set-up of an effective and efficient GMP manufacturing operation in our new manufacturing facility. The role will involve the generation and review of documents to facilitate the operation within the manufacturing centre; supporting technology transfer of the process from the US site and assays from the European site and training of junior operators in aseptic processing and other cleanroom activities such as environmental monitoring.
The ideal candidate will have experience of executing cell and gene therapy manufacturing processes in an aseptic cleanroom environment; manufacturing operations set-up and technology transfer.
Identifying, writing and reviewing of operational procedures and other documentation required to enable the manufacture of clinical product in the Manufacturing Centre including SOPs, IQ/OQ/PQs, risk assessments
Ensure that operational procedures are in-line with the CGT Catapult Manufacturing Centre requirements
Supporting the establishment of the supply chain systems to ensure that all materials and consumables are available for use with no delay to the manufacturing process
Supporting the technology transfer of processes and assays into the manufacturing facility including and support troubleshooting and process improvement
Supporting the execution of the manufacturing process, QC assays, cleaning and environmental monitoring activities
Training of junior members of the team in aseptic processing, cleanroom behaviours and other manufacturing activities
Supporting any other activities as required for start-up and operation of the manufacturing facility to meet business needs.