About the role
Job Description
* 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.
Qualifications
* 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.
Additional Information
All our positions are open to both women and men and are, of course, open to people with disabilities.