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
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
- Cognizant is a global community with more than 300,000 associates around the world.
- We don’t just dream of a better way – we make it happen.
- We take care of our people, clients, company, communities and climate by doing what’s right.
- We foster an innovative environment where you can build the career path that’s right for you.
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.
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, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.