Ztek Consulting · 4 hours ago
MES SUPPORT ENGINEER
Wilson, NC
Contract
Onsite
Senior Level
5+ years expZtek Consulting is seeking a MES Support Engineer with expertise in pharmaceutical manufacturing systems. The role involves configuring and maintaining Werum PAS X in compliance with GMP standards and integrating it with various peripheral systems.
ConsultingHuman ResourcesInformation TechnologyLegalStaffing Agency
Hiring Manager
Mazhar Shaikh
Responsibilities
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)
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
Qualification
Required
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)
5+ years of strong experience in PAS-X Modelling and Support
Pharmaceutical Process Knowledge & GxP Compliance
Technical Integration & Data Systems
Preferred
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
Company
Ztek Consulting
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for its clients.
201-500 employees
H1B Sponsorship
Ztek Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (1)
Funding
Current Stage
Growth StageLeadership Team
S
Shefali Sharma
Founder
Company data provided by crunchbase