Role details

Contract type

Temporary contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

5 years minimum

Working hours

Shift work

Languages

English

Job source

www.adzuna.de

Tech stack

System Configuration Data Integrity Electronic Signatures Systems Integration

Requirements

• Overall experience 5+ years experienced MES/MBR Designer)
• Relevant experience 5+ years (hands-on PAS-X MBR design and configuration experience)
• Mandatory skills required
• Hands-on experience designing, configuring, and building electronic Master Batch Records using Werum K rber PAS-X MES.
• Experience with PAS-X v3.4 or comparable PAS-X versions.
• Experience converting paper-based batch records into electronic MBRs.
• Knowledge of GMP manufacturing processes, pharmaceutical batch records, and data integrity requirements (ALCOA+).
• Experience configuring MBR logic, including calculations, branching, electronic signatures, exception handling, and material/equipment integration.
• Experience with MBR verification, testing, defect resolution, and change control.
• Ability to collaborate with manufacturing, QA, process owners, and automation teams.
• Good to have skills
• Experience with the Novartis Global MES Template.
• Experience in biologics, large molecule, or gene therapy manufacturing.
• Previous experience with global MES rollout projects.
• Experience with regulated pharmaceutical manufacturing environments.
• Required level of additional language English (business fluent). No additional language required.

Apply for this position

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Apply on www.adzuna.de

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