- Act as the primary escalation point for complex MES incidents and production issues.
- Configure, administer, and optimize MES functionalities supporting GMP manufacturing activities.
- Perform root cause analysis and implement permanent corrective actions.
- Support electronic batch records, manufacturing workflows, and production processes.
- Lead technical changes, deployments, and system enhancements.
- Collaborate with Quality Assurance, Validation, Manufacturing, Engineering, and IT teams.
- Ensure compliance with GMP, GxP, Computer System Validation (CSV), and Data Integrity requirements.
- Support audits and regulatory inspections.
- Mentor L1/L2 support teams and provide expert guidance.
- Participate in global MES improvement and digital manufacturing initiatives.
- Strong experience supporting and configuring Manufacturing Execution Systems.
- Proven experience in L3 Application Support, MES Engineering, or Manufacturing Systems.
- Solid understanding of GMP-regulated manufacturing processes.
- Experience with validation documentation (IQ/OQ/PQ) and CSV methodologies.
- Knowledge of batch record management and manufacturing execution processes.
- Strong troubleshooting and analytical skills.
- Experience with SQL, interfaces, and application integrations.
- Ability to engage with both technical and business stakeholders.
Nice to Have :
- Experience with Werum PAS-X (highly preferred).
- Knowledge of SAP-MES integrations.
- Familiarity with serialization and track & trace processes.
- Experience supporting biologics, vaccines, or pharmaceutical manufacturing sites.
- Experience participating in regulatory audits and inspections.
All our positions are open to both women and men and are, of course, open to people with disabilities.