Digital Transformation Expert

1 day ago


Mumbai, Maharashtra, India beBeemanufacturing Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

As a seasoned professional in the Indian pharmaceutical industry, we are seeking an experienced candidate to lead MES implementations and optimize manufacturing processes. The ideal candidate will have 10-15 years of experience with 3 years specializing in Manufacturing Execution Systems (MES) and Level 2 integration.

The role requires expertise in optimizing MES platforms such as Werum-PASX, Siemens Opcenter, and Rockwell PharmaSuite, as well as integrating Level 2 systems like SCADA, PLCs, and historians to enhance manufacturing efficiency and digital transformation. The candidate will ensure adherence to global regulations such as FDA 21 CFR Part 11, EU GMP, and GAMP5 while driving innovation in pharma manufacturing processes.

MES Leadership:

  • Lead MES implementation, upgrades, and harmonization across sites
  • Optimize workflows, such as batch records and electronic logbooks, to align with cGMP
  • Collaborate with IT and OT teams to ensure seamless MES-ERP integration

Cross-Functional Collaboration:

  • Mentor teams on MES Level 2 best practices and digital tools, IIoT, and Industry 4.0
  • Work with QA teams during audits
  • Streamline processes with QA, production, and supply chain teams

Innovation:

  • Identify opportunities for advanced analytics, AI, ML, and paperless manufacturing
  • Stay updated on emerging technologies and regulatory trends

Qualifications:
Bachelor's degree in Chemical Pharma Engineering, Computer Science, or related field;
Master's degree preferred;
10 years of experience in pharma manufacturing operations, with 3 years in MES implementations, experience in doing L2 integrations and OT setup highly valued;
Hands-on experience with MES platforms such as Werum PAS-X, preferably with proficiency in L2 systems;
Strong grasp of ISA-95 standards, 21 CFR Part 11, and data integrity principles;
Skills: project management, Agile Waterfall, leadership, technical troubleshooting, scripting (SQL, Python), excellent communication for stakeholder alignment, certifications (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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