About the Company:
Our client are at the forefront of immunotherapy and engineered T cell therapy. They are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
In this role you will be part of a team responsible for deploying, maintaining and implementing changes in computerized systems in manufacturing (MES, LIMS, ERP etc) and plays a central role in the digitalization of manufacturing in commercial manufacturing site.
Your responsibilities- Understand the process and user requirements driven by process maps / flows in preparation for developing or updating EBR designs
- Convert process and user requirements into specific EBR designs and design elements.
- Drive and support EBR design verification activities
- Manage EBR approval and retirement workflows to ensure correct record state
- Lead MES projects and change implementations
- Escalate business continuity impacting issues to Process Owner and respective tier
- Support EBR impact assessments based on the manufacturing/business process requirements and changes
- Identify and document MES (business) and manufacturing process requirements.
- Create and update Process SOPs, MES SOPs, and MES work instructions
Your profile- Bachelor’s degree or equivalent experience
- 5 years’ relevant (process engineer/MES specialist) experience within a Pharmaceutical/GMP Manufacturing site
- Experience with writing and execution of CSV documentation / protocols
- Experience with quality systems (change controls, deviations and CAPAs) in a pharmaceutical environment
- Knowledge of PAS-X version 3 is a plus
- Experience with SQL and XML coding with respect to MES is a plus
- Knowledge of the MES database and data elements as part of querying and reporting is a plus
- Good English language skills
Interested? If you see yourself in this role then click on this apply button and you will get to know more about this role.