Description

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 with structured problem-solving approach

• Excellent communication skills - 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