Digitalization MES (Functional & IT Technical)

We're Hiring | Deputy Manager/Associate Manager /Manager- MES (Functional & Technical)

Location: SEZ-II, Ahmedabad

Department: Digitalization

Role -MES (Functional & Technical)

Designation: Deputy Manager/Associate Manager /Manager

Zydus is seeking an experienced MES (Manufacturing Execution System) professional to drive our digital manufacturing transformation journey through MES and eBMR implementation. The role will encompass both Functional MES and Technical MES/IT responsibilities, enabling seamless integration between manufacturing operations and digital technologies.

Role 1: MES Functional Lead

Key Responsibilities :

• Lead MES/eBMR implementation projects across pharmaceutical manufacturing sites.
• Conduct requirement gathering workshops with Manufacturing, Quality, Engineering, and Business stakeholders.
• Prepare and review URS, Functional Specifications, VMP, IQ/OQ/PQ, and validation documentation.
• Configure MES workflows aligned with manufacturing and quality processes.
• Drive user adoption through training, workshops, and change management initiatives.
• Ensure compliance with GxP, Data Integrity, 21 CFR Part 11, ISA-95, and GAMP standards.
• Coordinate with vendors and cross-functional teams to deliver successful MES deployments.

Required Expertise

• Hands-on experience with Koerber PAS-X MES and eBMR implementation.
• Strong understanding of pharmaceutical manufacturing processes.
• Experience in Computer System Validation (CSV) and qualification activities.
• Knowledge of GxP regulations, Data Integrity, ISA-95, and GAMP guidelines.

Role 2: MES Technical / IT Lead

Key Responsibilities :

• Design, implement, and support MES architecture and infrastructure.
• Manage MES master data, electronic logbooks, workflows, and system configurations.
• Lead MES integrations with SAP, LIMS, SCADA, DCS, PLCs, Historian, and other enterprise systems.
• Support cloud/on-premise deployments across AWS, Azure, Windows, and Oracle environments.
• Troubleshoot application, database, hardware, and integration-related issues.
• Develop reports, dashboards, and analytics solutions for manufacturing operations.
• Support system upgrades, audit readiness, cybersecurity, and compliance requirements.

Required Expertise :

• Strong technical knowledge of PAS-X configuration and integration.
• Experience with Oracle, SQL, XML, HTML, and reporting tools.
• Knowledge of Kepware, OPC communication, SCADA, DCS, and PLC systems.
• Understanding of MES architecture, infrastructure, and industrial automation environments.

Experience & Qualification

7-12 Years of experience in MES implementation and digital manufacturing projects within the Pharmaceutical industry.

Hands-on experience in:

• PAS-X MES
• eBMR Implementation
• Software Validation
• System Integration
• Digital Transformation Projects

Qualification:

• B.E./B.Tech (IT, Computer, Electronics, Instrumentation)
• MCA
• Equivalent qualification with proven MES expertise.

Preferred Candidate Profile

• Strong experience in Pharmaceutical / Life Sciences manufacturing.
• Ability to bridge business requirements and technical solutions.
• Proven stakeholder management and project leadership skills.
• Experience leading end-to-end MES implementation projects.