Job Summary We are seeking an experienced Senior MES Lead MES Solution Architect with deep expertise in pharmaceutical manufacturing GxP systems and MES recipe authoring The role involves end-to-end MES implementation including process design EBR MBR development validation CSV system integration and team leadership The candidate will work closely with clients at manufacturing sites to drive digital manufacturing transformation aligned with ISA-88 GAMP 5 and global regulatory standards Key ResponsibilitiesMES Digital Manufacturing Lead discovery workshops at client sites to understand manufacturing processes user requirements and business needs Analyze business process flows identify gaps and design operations unit procedures and recipes aligned with ISA-88 standards and Manufacturing Batch Records MBR Design configure and implement Electronic Batch Records EBR within MES platforms Execute end-to-end dry runs and deploy validated master recipes prior to Go-Live Ensure successful production runs by risk assessment troubleshooting deviation investigation and MES issue resolution MES Platforms Integration Hands-on experience with MES platforms such as Siemens Opcenter Werum PAS-X Tulip Define and support solution architecture including Hardware software and network components Integration with ERP LIMS QMS L2 systems Support integration of weighing scales barcode scanners printers and shop-floor equipment Configure customer-specific system settings and reporting solutions MS SSRS Validation Compliance CSV Define and manage the Project Validation Plan PVP Prepare and maintain validation deliverables IQ OQ PQ Risk Assessment Impact Assessment Traceability Matrix RTM Lead GxP assessments system-level and functional risk analysis Manage protocol execution review and approvals in collaboration with customer validation teams Ensure compliance with 21 CFR Part 11 EU Annex 11 ICH Guidelines ISPE GAMP 5 Leadership Stakeholder Management Manage and mentor a team of MES Process Engineers Act as a key interface between clients internal teams quality and IT stakeholders Participate in internal and external audits inspections Develop reusable templates workflows and building blocks to support scalable MES delivery Effectively communicate complex technical and regulatory concepts to stakeholders and inspectors Required Skills ExperienceExperience 8 years of experience in pharmaceutical or biotech manufacturing environments Solid background in MES EBR Automation SCADA Historian and validation projects End-to-end experience across the full project lifecycle design build test validation go-live Experience leading medium to large pharma MES programs Job Type Full-time Pay 100 985 52 - 163 474 62 per month Work Location Remote

📌 Senior Mes Lead / Mes Solution Architect – Pharma & Biotech 8+yrs (India)
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📍 India