
MES Engineer - Sterile Manufacturing
- Haarlem, Noord-Holland
- Vast
- Voltijds
- 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
- Competitive Salary: We offer a salary that reflects your skills and experience.
- Bonus based on personal and company performance
- 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