onsite on manufacturing sites in France, Italy, and Spain
Role Overview:
We are seeking a detail-oriented MBR Designer to support the deployment and optimization of electronic batch recording (EBR) systems across multiple European manufacturing sites. This role is key to translating manufacturing processes into GMP-compliant Master Batch Records using industry-leading MES platforms.
The ideal candidate will have hands-on experience designing MBRs within a regulated pharmaceutical environment, strong cross-functional collaboration skills, and the flexibility to work across culturally diverse teams.
Responsibilities:
Proven experience designing and maintaining MBRs in a GMP-regulated pharmaceutical or biotech environment.
Hands-on experience with EBR / MES systems such as Werum - PAS-X.
Strong understanding of batch manufacturing processes, process mapping, and documentation practices.
Familiarity with regulatory requirements including EU GMP, FDA, and Annex 11.
Excellent communication and collaboration skills; ability to work with cross-functional and multicultural teams.
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