Job description
Job Summary
We have a fantastic opportunity for an Instrument & Controls Engineer to join our Engineering team supporting our GMP Cell Manufacturing operations in Stevenage. The focus of the role will be:
- 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.
The role will be working Friday to Monday every week. The shifts will then rotate every 2 weeks between 6am to 3.45pm / 12.15pm to 10pm.
Some of the duties will include:
- 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 areas.
- Respond to CAPA actions to ensure timely close out of all Quality issues associated with Engineering and Facilities