Bachelor's degree in Engineering, Computer Science, Information Systems, or equivalent practical experience.
Proven hands-on experience configuring and maintaining Werum PAS X (MES) in pharmaceutical or biotech manufacturing environments.
Strong understanding of pharmaceutical GMP, electronic batch records, and computerized system validation (CSV), including IQ/OQ/PQ documentation.
Practical knowledge of MES concepts and standards (ISA 88, ISA 95) and how they map to PAS X configuration.
Experience integrating PAS X with peripheral systems: SAP (PP/PI or MII), LIMS, ERP, PLC/SCADA, and historians (interfaces via IDocs, XML/REST, OPC, or web services).
Strong troubleshooting and test-case execution skills, with attention to traceability and regulatory compliance during deployments and change management.
Excellent communication skills, ability to work with cross-functional teams (TQ /EQ, Production, IT).
Preferred / Nice-to-have:
Previous involvement in full lifecycle MES implementations (requirements, design, build, test, go live, hypercare).
Knowledge of electronic signatures, audit trails, and 21 CFR Part 11 requirements.
Certifications in PAS X.
Top Skills:
- 5+ years of strong experience in PAS-X Modelling and Support
- Pharmaceutical Process Knowledge & GxP Compliance
- Technical Integration & Data Systems
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