Process Scientist required for global pharmaceutical company based in Dublin.
We are currently recruiting for an exciting opportunity for a Process Scientist position, this is a permanent role within the Drug Substance team.
In this role, you will be responsible for supporting upstream and downstream processing.
The process scientist is responsible for ensuring that the process is running as intended and that all technical issues are resolved to support the technical transfer and validation of new products.
You will be involved in leading and resolving technical issues within the operations unit, including process/equipment troubleshooting, investigating deviations, identification and implementation of CAPAs and process improvements.
- Provide routine process technical support, trouble-shooting and resolution of manufacturing process and technology issues to ensure the successful completion and disposition of batches in a timely manner.
- Experience writing technical documents, including SOPs, batch records that describe protein manufacturing unit operations and processes.
- Troubleshoot issues arising through the Investigation (ER / QAR) process including but not limited to leading technical investigations and supporting the implementation of immediate CAPAs.
- Identify and implement improvements to recurring equipment, process and procedural inefficiencies.
- Perform real time Process Monitoring and data collation to support troubleshooting
- Support the document periodic review process.
- Competent with Quality Systems including Manufacturing Investigations, Change Controls and Commitments and Maintenance systems.
- Be competent in developing Technical/ product/process impact assessments in support of investigation closures.
- Implement short term process corrective actions and performance improvements.
- Raise and execute change controls for Technical Operations.
- Provide technical training on process and technology areas as required by Operations.
- Identify process improvement projects to Core Technical Services.
- Support Compliance Inspections and enquiries from Regulatory Agencies.
Education and Qualification:
- Degree in Bioprocessing Science, Engineering, Biotechnology or equivalent
- Experience and knowledge of biological manufacturing processes, including key processing parameters and their effect on batch performance.
- Minimum of 5 Years cGMP industrial experience.
- Experience of FDA and EU licensing inspections.
- Fully Proficient as a Proteins Process Scientist SME eitherupstream or down but preferable both.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.