Job Responsibilities Requirements& Analysis Engage Business SMEs and Key Users to elicit, analyse, and document functional and technical requirements Author User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) Map common processes across manufacturing sites to enable Global PI design Solution Design & Configuration Design site-specific and global Process Instructions (PIs) aligned to GMP requirements Configure Opcenter Execution Pharma / Simatic IT eBR modules end-to-end Collaborate with MES engineers on integration design with ERP, LIMS, and DCS/SCADA systems Validation& Quality Lead validation activities in compliance with GxP, 21 CFR Part 11, and EU Annex 11 Develop IQ/OQ/PQ test scripts, Design Specifications, and Traceability Matrices Support defect resolution and change management throughout delivery Documentation Maintain comprehensive documentation: URS, FRS, Design Specs, Test Scripts, and SOPs Ensure all artefacts meet internal quality standards and client requirements Team Leadership & Stakeholder Management Lead and mentor junior consultants; assign tasks and provide technical guidance Report project status, risks, and issues to Cognizant and client management Facilitate workshops, training, and knowledge transfer sessions Job Requirements Experience (Essential) Minimum 5 years of hands-on MES implementation experience, with strong expertise in Siemens Opcenter Execution Pharma (Simatic IT eBR) or equivalent pharma MES platform Proven delivery track record in pharmaceutical, biotech, or life sciences projects Solid exposure to GxP-regulated environments; working knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 Demonstrated ability to gather requirements and author functional specifications Experience leading or mentoring team members in a project setting Technical Skills Strong proficiency in Opcenter Execution Pharma / Simatic IT eBR configuration and PI design Good understanding of MES integration patterns (ERP, LIM