Our multi-functional Validation team is delighted to be able to offer opportunities to developing Validation professionals to progress their careers with us in the exciting area of cell & gene therapy manufacturing and development.
Oxford Biomedical is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient's cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market
The Oxford Biomedica Validation Team work across GMP manufacturing and laboratory facilities by ensuring all aspects of validation (manufacturing & laboratory equipment, facilities and utilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are appropriately addressed. This environment provides our Validation Specialists with vast opportunities to gain experience, allowing them to grow and prosper with us.
Key Duties & Responsibilities:
- Supporting the validation of OXB's equipment, facilities, utilities and processes in accordance with GMP requirements
- Supporting system owners in preparing user requirement specifications (URS), conducting design qualification (DQ) studies and system/equipment selection
- Preparing and maintaining validation plans (VPs), assisting system owners with impact assessments and identifying validation requirements
- Executing validation protocols (equipment, facilities, utilities, computerised systems and processes)
- Critically reviewing the results of validation studies and effectively managing/closing-out any deviations
- Generating validation reports before handover/return to system owner and updating the relevant systems/schedules
- Managing the requalification of systems and equipment in accordance with approved plans and procedures to maintain the 'validated state'
You will need:
- A Degree (or equivalent) in a Science / Engineering or related discipline
- A working knowledge of biopharmaceutical and pharmaceutical industry regulations and guidelines as they relate to qualification/validation of OXB's equipment/systems, facilities, utilities and processes
- Demonstrable experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation/execution of lifecycle documents (URS, DQ, IQ, OQ & PQ )in a biopharmaceutical, pharmaceutical or related industry
- Understanding and experience of aseptic processing and cleanroom technologies highly desirable
We look forward to receiving your application.