Mes Team Member-digital Transformation

5 days ago

Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full time

Job Summary We are looking for a seasoned professional with 10-15 years in the Indian pharmaceutical industry including 3 years specializing in Manufacturing Execution Systems MES and L2 integration This role demands expertise in optimizing MES platforms e g Werum-PASX Siemens Opcenter Rockwell PharmaSuite and integrating Level 2 systems SCADA PLCs historians to enhance manufacturing efficiency compliance and digital transformation The ideal candidate will ensure adherence to global regulations FDA 21 CFR Part 11 EU GMP GAMP5 while driving innovation in pharma manufacturing processes Experience with implementing greenfield MES and or being part of core team from inception will be a big plus Key Responsibilities MES Leadership - Lead MES implementation upgrades and harmonization across sites - Optimize workflows e g batch records electronic logbooks to align with cGMP - Collaborate with IT OT teams to ensure seamless MES-ERP e g SAP integration Cross-Functional Collaboration Mentor teams on MES L2 best practices and digital tools IIoT Industry 4 0 Work with QA teams during audits Work with QA production and supply chain to streamline processes Innovation Identify opportunities for advanced analytics AI ML and paperless manufacturing Stay updated on emerging technologies and regulatory trends Qualifications Education Bachelor s in Chemical Pharma Engineering Computer Science or related field Master s preferred Experience - 10 years in pharma manufacturing operations with 3 years in MES implementations experience in doing L2 integrations and OT setup will be a big advantage - Hands-on experience with MES platforms e g Werum PAS-X preferred if also proficient on L2 systems Ignition SCADA OSIsoft PI etc - Strong grasp of ISA-95 standards 21 CFR Part 11 and data integrity principles will be a plus Skills - Project management Agile Waterfall and leadership - Technical troubleshooting and scripting SQL Python - Excellent communication for stakeholder alignment - Certifications Preferred PMP Six Sigma GAMP5 Preferred Skills Experience with ERP interfaces SAP S4HANA and L2 integration Experience on cloud-based MES and L4 integration a plus Knowledge of data analytics tools Power BI Tableau and IIoT platforms

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