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Skills
Biotech and Pharmaceuticalunmatched
Change Managementunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Scienceunmatched
Cross-Functionalunmatched
Documentationunmatched
Drug Manufacturingunmatched
ERP (Enterprise Resource Planning)unmatched
GMP (Good Manufacturing Practices)unmatched
Health Planunmatched
ISA Standardsunmatched
Information Technology & Information Systemsunmatched
Information Technology Consultingunmatched
Laboratory Information Management System (LIMS)unmatched
Process Validationunmatched
Programmable Logic Controller (PLC)unmatched
REST (Representational State Transfer)unmatched
Regulatory Complianceunmatched
SAPunmatched
Supervisory Control and Data Acquisition (SCADA)unmatched
System Validationunmatched
Technical Supportunmatched
Test Caseunmatched
Testingunmatched
Traceabilityunmatched
Web Servicesunmatched
XML (EXtensible Markup Language)unmatched
Description
Our Client, an IT Services and Consultant company, is looking for a PASX Support engineer for their Remote location.
Requirements:
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).
Working experience in PASX V3.1.8
3+ years of Relevant PAS-X experience
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.