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
What we offer
- The chance to work with impact. Here, you’re empowered to bring your biggest thinking to help our company and clients improve everyday life.
- Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
- The opportunity to thrive on a high caliber team with heart. We celebrate each other’s experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
- A comprehensive total rewards package, including a competitive salary and a pension plan with matching contributions.
- Flexible health and financial benefits to support you and your eligible dependents—from day one.
- True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.
About us
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.
Other employment-related information
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, provincial or local laws.
If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.
Language requirements vary depending on roles, but we ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you’ll deliver services to and collaborate with stakeholders outside the province who may not speak French.
