Process Engineer Cell Therapy
My client is a large international pharmaceutical company located in the Randstad Area specialized in Cancer Treatment. With around 2000 employees worldwide they keep expanding and look for motivated people to join their organization where you will contribute to a great cause.
In this role, you will be working on a global project to implement a Manufacturing Execution System and Electronic Batch Record on a production site.
- Participate in the design and implementation of EBR within MES
- Provide front line technical support for manufacturing during MES engineering and validation runs
- Collaborate with various internal and external stakeholders to investigate and coordinate the resolution of project related deviations through comprehensive use of Root Cause Analysis tools and product impact assessments.
- Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
- Conduct technical training to Cell Therapy Specialist
- Bachelor in Biochemical Engineering, Chemical Engineering or Biotechnology
- 4 years of relevant industry experience
- Cell therapy, cell culture and/or aseptic processing experience
- Basic knowledge of cGMP compliance
- Experience with root cause analysis tools and proficiency in Quality Systems
- Experience leading cross functional teams
- Knowledge of MES
- Currently living in The Netherlands
- Flexibility in working hours required, due to collaborating with US colleagues