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    R&D Process Engineer - Cambridge, Cambridgeshire, United Kingdom - Adepto Technical Recruitment Ltd

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

    An exciting opportunity for an established Process Development Engineer 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.

    As the Process Development Engineer your role will be varied and exciting.

    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.
    • To be considered for the Process Development Engineer role, you will have a keen eye for detail, a strong communicator who is able to manage multiple tasks at one. 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.

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