Our client is a biopharmaceutical pioneer engaged in the development of cancer immunotherapies with the aim to provide long term response and eliminate this chronic disease.
As a Process Engineer, you will provide expertise for technology transfers, process validations, and GMP manufacturing, while writing reports and assessments for deviations and change controls. Additionally, you will be working with the Process Development, Quality, and Manufacturing teams for the Manufacturing Science and Technology department.
- Act as a process development representative
- Monitor process and product impact and write assessments
- Perform root-cause analyses, deviation resolutions, risk assessments and remediation measures
- Write SOPs, batch records, etc.
- Lead continuous improvement projects
- Evaluate new technology and process automation for introduction into GMP manufacturing
- Collaborate with stakeholders
- Degree in Life Sciences, Engineering, Biotechnology, or similar
- Minimum 3 years of pharmaceutical manufacturing, technology transfer, or process development experience
- Experience working with cGMP
- Previous experience with cell therapy products is a plus
- Ability to think critically and demonstrate troubleshooting and problem solving skills
Ready for the next step in your career? Do you have any questions? Please reach out to me by applying to this vacancy.