Manufacturing Process Engineer
Location: HoofddorpAbout 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.
Department Description:
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
- Create and update Process SOPs, MES SOPs, and MES work instructions
Your profile
- Bachelor’s degree or equivalent experience- 5 years’ relevant experience within a Pharmaceutical/GMP Manufacturing site
- Experience with writing and execution of 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
- Good English language skills
Other Information
Are you ready to the next step in your career? Fill out your application by using the apply button and don’t hesitate to contact me
