About this role
Roles & Responsibilities 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, LIMS, DCS/SCADA, historians) • Familiarity with batch manufacturing, dispensing, packaging, and QC workflows • Competency in validation methodology and documentation standards • Working knowledge of SQL or data query tools is advantageous Competencies • Analytical mindset withstructured problem-solving approach • Excellent communicationskills — effective with both technical and business audiences • High attention to detail and commitment to quality outcomes • Self-motivated; thrives independently and in collaborative team settings Qualifications • Degree in Engineering, Computer Science, IT, Pharmacy, or related discipline • Opcenter / MES certifications are advantageous
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