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