Hobson Prior is currently recruiting a Process Engineer to join our Manuf. Ops team. This role will provide technical-operational knowledge to the Good Manufacturing Practice operations at decentralized manufacturing units in Europe.

The successful candidate will be a subject matter expert on the manufacturing process during operations of automated CAR-T, helping to drive operations through clinical/pivotal/commercial readiness.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Lead the Manuf. Ops team in activities such as process monitoring, deviation triage, technical support, issue resolution, process and equipment troubleshooting.
• Coordinate activities, continuous development and improvement of systems and procedures related to decentralized manufacturing unit operations.
• Support the process engineers within the team with the routine communication between the manufacturing team and decentralized manufacturing units.
• Maintain oversight of decentralized manufacturing unit status in alignment with internal and external stakeholders.
• Address operational challenges and deviations within the manufacturing process with internal stakeholders and decentralized manufacturing units to ensure compliance and qualification.
• Ensure consistency and control of the manufacturing processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports relating to clinical readiness and Tech Transfer.
• Perform data trending and analysis for Key Performance Indicators related to operational performance of manufacturing.

Key Skills & Requirements:

• Degree in life sciences, biotechnology, engineering or related discipline.
• Experience with cell & gene therapy processes, automated bioreactors, Good Manufacturing Practice manufacturing, technology transfer, process validation and/or process development.
• Experience of Frontline Support activities and the coordination of activities related to this.
• Experience of people/project management.
• Experience of management of quality records and documentation review and writing.
• Result-driven and can-do mindset, without compromising quality and compliance.
• Responsibility for own projects while pursuing company goals in open collaboration.
• Good interpersonal skills and written and spoken fluency in English.

For more information please contact Jack Keens.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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