We are currently hiring for a Lead Design Engineer - PAS-X MES position with our client LTTS. This is a great opportunity for candidates with strong hands-on experience in PAS-X MES design, validation, and manufacturing system integration within regulated environments.
Position Details
Role: Lead Design Engineer - PAS-X MES
Location: Duluth, Georgia (Onsite/Hybrid - as per client requirements)
Key Responsibilities
Design, configure, and maintain Master Batch Records (MBRs), master data, workflows, and business logic in PAS-X v2
Support and troubleshoot PAS-X integrations with ERP (SAP), LIMS, PLC/SCADA, and other shop-floor or enterprise systems
Provide L2/L3 production support, including incident resolution, root-cause analysis, and execution of change management activities
Actively participate in system validation efforts, including preparation and execution of URS, FRS, IQ, OQ, and PQ
Ensure systems comply with GAMP 5, 21 CFR Part 11, and EU Annex 11 regulatory requirements
Work closely with Manufacturing, Quality Assurance, and IT teams to support production and continuous improvement initiatives
Support documentation, audit readiness, and regulatory inspections as required
Required Qualifications
Bachelor's or Master's degree in Instrumentation & Control, Electronics, Computer Engineering, or a related discipline
Strong hands-on experience with PAS-X MES (v2 preferred) in Pharma, Biotech, or Life Sciences environments
Solid understanding of MES validation, compliance standards, and SDLC in regulated industries
Experience working in cross-functional, global teams
Nice to Have
Experience with SAP MES integrations
Prior exposure to manufacturing execution systems support in production environments
Familiarity with CSV documentation and audit support
Numbers & Facts
Location
Georgia, GA
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Managementunmatched
Code of Federal Regulationsunmatched
Computer Engineeringunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Electronic Engineeringunmatched
Environmental Sciencesunmatched
Identify Issuesunmatched
Instrumentationunmatched
Laboratory Information Management System (LIMS)unmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
Manufacturing Systemsunmatched
Process Validationunmatched
Production Supportunmatched
Production Systemsunmatched
Programmable Logic Controller (PLC)unmatched
Quality Assuranceunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Root Cause Analysisunmatched
SAPunmatched
SAP ECC (fka SAP R/3 and SAP ERP)unmatched
Software Development Lifecycle (SDLC)unmatched
Supervisory Control and Data Acquisition (SCADA)unmatched
Support Documentationunmatched
System Integration (SI)unmatched
System Validationunmatched
Systems Administration/Managementunmatched
Technical Supportunmatched
Technical/Engineering Designunmatched
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