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Process Development Engineer

4 months ago

Cambridge Cambridgeshire, United Kingdom Adepto Technical Recruitment Ltd Full time €45,000 - €55,000

Permanent role
Personal Days, Private Medical Cover, Enhanced MAT/PAT Leave, Bonus & more

An exciting opportunity for an established Technical Process Specialist has arisen to join a global leader in contract manufacturing for pharmaceuticals and drug delivery.

You will be responsible for the development and improvement of manufacturing processes, creating quotations for process development & manufacturing work, as well as supporting with technical troubleshooting of Fill Finish Processes.

Draft, write and review process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to GMP manufacturing.

* Collaboratively improve and/or troubleshoot manufacturing processes and propose needed protocols for data collections and/or experimentation.

* To be the technical author of deviation impact assessments which feed into the Quality Management System.

* Risk analysis of processes including prioritisation and implementation of mitigations.

* BEng Chemical Engineering

* Previous relevant Process Development/MSAT function experience.

* Manage CMOs and Suppliers in technical and project planning activities for process development, technology transfer and validation.

* Validation activities including specification writing, qualification testing and reporting.

* Experience working under the ISO13485 and GMP quality systems.

* Experience in risk assessment and risk management.