Teva MES Engineer - Sterile Manufacturing 

Netherlands, North Holland, Haarlem 

678037735

As MES Engineer, you are the operational and strategic backbone of our Manufacturing Execution System (PAS-X Werum) within Sterile Manufacturing. You’ll ensure smooth day-to-day operations, continuously improve batch designs, and act as our linking pin for the transition to a full electronic Batch Manufacturing Record (e-BMR).

• Provide hands-on support to shopfloor users and super-users to resolve day-to-day MES issues.
• Configure, test & release PAS-X Master Batch Records (MBRs) and workflows per GMP requirements.
• Continuously improve MES batch designs to boost right-first-time execution and data integrity.
• Translate production and QA requirements into scalable PAS-X solutions.
• Ensure seamless PAS-X ↔ SAP integration for materials, orders, equipment and logistics.
• Lead investigations of MES-related deviations and drive CAPA implementation.
• Support audit readiness and compliance (21 CFR Part 11, EU Annex 11).
• Act as strategic liaison for Teva Haarlem’s future e-BMR roadmap.

• Bachelor’s in Engineering, Life Sciences, Computer Science, or related field.
• ≥ 3 years MES experience in GMP pharma manufacturing (sterile production preferred).
• Deep hands-on expertise with Werum PAS-X; solid SAP logistics integration experience.
• Proven track record in real-time MES troubleshooting and user support.
• Strong grasp of GMP, data integrity, electronic records, and CSV validation.
• Excellent communicator, able to bridge operations and digital teams.
• Fluent in English; Dutch is a plus.

• MES Training Coordinator Experience
  – Served as MES training coordinator for end-users, ensuring efficient system usage.
• e-Batch Record Simplification
  – Simplified electronic batch records to eliminate human errors and exceptions.
• SME for Fill-Finish & Compounding
  – Acted as Subject Matter Expert for manufacturing fill-finish line and compounding operations.
• Recipe Preparation & Execution
  – Prepared and executed MES recipes using Werum PAS-X.
• SAP ↔ PAS-X Integration
  – Streamlined operations by integrating SAP material flows into PAS-X for smooth system functionality.
• MBR Design & Revision
  – Proficiently designed new MBRs and revised existing ones in PAS-X, leveraging a library of work instructions; iteratively refined records based on test-phase feedback with full approval governance.
• Shopfloor Business Team Collaboration
  – Experienced in supporting operators to understand and effectively use MES on the shopfloor.

Ivo Huijskens - Senior Recruiter

Associate Director Production Steriles

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