Production Expert II
Haarlem, Netherlands, 2031
Who we are
The opportunity
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).
How you’ll spend your day
- 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.
Your experience and qualifications
- 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.
Ideal candidate
- 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.
Enjoy a more rewarding choice
- Competitive Salary: We offer a salary that reflects your skills and experience.
- Bonus based on personal and company performance.
- Flexible Working Conditions: Enjoy the benefits of our hybrid work policy.
- Comprehensive Pension Plan: Includes occupational disability insurance and partner and orphan insurance.
- Generous Vacation: 25 paid vacation days, plus a Personal Choice Budget of 11.5 days based on full-time employment
- Parental Leave: Benefit from 9 weeks of fully paid parental leave.
- Wellbeing Initiatives: Take advantage of our bike plan, caregiver policy and more
Contact person
Ivo Huijskens - Senior Recruiter
Reports To
Associate Director Production Steriles
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