MES Lead

Job Description

Position: MES Lead – ( PAS-X & L2 Equipment Integration )
Location: Hyderabad
Department: IT & Digital
Reports To: Head – Digital Manufacturing & Quality
Role Type: Full-Time, Permanent

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Role Overview

The MES Lead will be responsible for leading the design, deployment, and support of the Werum PAS-X MES platform across all manufacturing facilities. The role requires strong expertise in L2 (PLC/SCADA/DCS) integration with equipment and ensuring seamless, compliant, and efficient execution of manufacturing processes. This role is central to driving data integrity, digital batch processing, and manufacturing excellence aligned with cGMP requirements.

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Key Responsibilities

• Strategic Leadership
• Act as the functional and technical lead for MES (PAS-X) implementation and continuous improvement across all production facilities.
• Define MES roadmap aligned with the organization's digital manufacturing strategy.
• Ensure alignment with corporate IT/OT architecture standards and regulatory compliance requirements.
• MES - PAS-X Ownership
• Lead design and deployment of Electronic Batch Records (eBR) and process workflows in PAS-X.
• Manage PAS-X configuration, master data, recipe design, and change requests across sites.
• Drive MES harmonization across multiple facilities to ensure standardization and scalability.
• Integration with Enterprise systems such as SAP, LIMS etc
• L2 Equipment Integration (Automation/OT systems)
• Lead integration of Level 2 systems (PLC/SCADA/DCS) with PAS-X for automated data capture and real-time control.
• Collaborate with automation engineers, process engineers, and vendors to design standardized interfaces (e.g., OPC, ISA-95).
• Ensure robust and validated data transfer between equipment and MES, supporting regulatory compliance.
• Cross-Functional Collaboration
• Partner with Manufacturing, Quality, Regulatory, and Engineering teams to translate process needs into MES solutions.
• Coordinate with IT infrastructure and cybersecurity teams to ensure secure, compliant systems.
• Manage vendor relationships for MES and OT system integration.
• Compliance & Validation
• Ensure MES implementations adhere to GMP, FDA 21 CFR Part 11, GAMP5, Annex 11, and other applicable regulations.
• Oversee system qualification, validation deliverables, and audit readiness.

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Qualifications & Experience

• Education:
• Bachelor’s degree in Engineering, Computer Science, Information Systems, or related discipline (Master’s preferred).
• Professional Experience:
• 6 - 12 years of experience in IT/OT systems for Life Sciences manufacturing, with minimum 5+ years direct experience in Werum PAS-X MES implementation & administration.
• Proven track record of L2 equipment integration with MES in a regulated pharmaceutical environment.
• Strong understanding of GMP regulations, Data Integrity, and Computer System Validation (CSV).
• Experience in managing multi-site MES rollouts is highly desirable.
• Technical Competencies:
• Expertise in Werum PAS-X MES modules (Weighing & Dispensing, EBR, Master Batch Records, Logbook etc).
• Strong knowledge of automation systems (PLC/SCADA/DCS).
• Strong knowledge of Integration with Enterprise Systems such as SAP, LIMS etc
• Familiarity with OPC UA, ISA-95/ISA-88 standards, and manufacturing data integration frameworks.
• Understanding of database systems (Oracle, SQL) and IT infrastructure supporting MES.
• Leadership Competencies:
• Strong stakeholder management, vendor management, and cross-functional leadership skills.
• Excellent problem-solving, decision-making, and program management capabilities.
• Ability to lead transformation initiatives across global/regional sites.