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 L2L3 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 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 ----------------------
• Bachelors or Masters 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.