- To provide engineering support to all Manufacturing and QC operations at Autolus facilities at Stevenage.
- To help develop engineering processes and systems including asset management, maintenance and continuous improvement.
- To ensure ongoing compliance with all Quality and statutory regulations and best practices.
- Interface with CGTC Engineering department to ensure compliance with all processes and systems.
- To support and provide first fix capacity for manufacturing and analytical equipment
- To manage contractors on site, monitor and review activities and subsequent paperwork and reports
- Write, review and update maintenance procedures for equipment and systems
- Work within the QMS ensuring deviations change control and CAPAs are managed and executed effectively
- Provide liaison with CGTC engineering team to ensure activities are performed effectively and to address facility issues that impact Autolus operations
- Provide support where necessary to the validation team for requalification activities
- Manage Autolus owned systems such as P-EMS
- Provide engineering support for wider project activities within the manufacturing and QC
- Respond to CAPA actions to ensure timely close out of all Quality issues associated with
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