Description

You will manage the creation, validation, and troubleshooting of electronic batch records (EBR) within a biopharmaceutical manufacturing environment. You translate process specifications from development teams into electronic source documents for production.

Responsibilities

• Create and edit Global Manufacturing Batch Records (GMBR) and Parameter Value Lists within the MES and ERP systems.
• Manage EBR validation for new or modified processes and provide real-time troubleshooting during manufacturing.
• Support the implementation of new MES functionality and contribute to projects introducing new manufacturing technologies.
• Perform data verification, document management, and SOP revisions to ensure quality compliance.

Required Skills

• 5+ years of software development or manufacturing-related experience.
• Direct experience with Client-X Werum software for electronic batch records.
• Background in drug product manufacturing within a biopharmaceutical setting.
• Proficiency with .NET Framework.
• Strong understanding of translating paper-based instructions into electronic systems.
• Demonstrable attention to detail and a quality-based mindset.
• Ability to manage complex electronic data entry according to Standard Operating Procedures (SOP).

Preferred Skills

• Bachelor's degree in Engineering, Biological Sciences, or a related graduate field.

Key Skills

Education

Any Graduate