Process Engineer - Pharma or Bio support of drug product manufacturing
The Process Engineer will provide process development technical support to large molecule and small molecule drug product manufacturing as well as being part of the global Process Development organisation. The input provided will include support of process performance and implementation of process improvement strategies.
* Degree and over 6 years similar experience
* Direct industrial experience in the field of lyophilisation, specifically related to cycle development, scale up & technology transfer, in-silico modelling & optimisation, commercial support, process monitoring and troubleshooting
* 10 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterisation, Tech Transfer (to commercial DP sites) or Validation
* Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for parenteral products.
* Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterisation, Tech Transfer and Validation. Supports commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer.
* Troubleshoots issues with drug product processing technologies and equipment.
* Develop and characterise drug product processes and transfer technology to commercial drug product sites.
* Conduct risk assessment for drug product operations and propose / implement appropriate CAPA.
* Identify and implement operational opportunities for current and new sterile operations.
>This is an intital 18 month assignment
For more information on this role and a confidential discussion please contact Eleanor Collins @ Morgan McKinley 021 2300 300 / firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.