Principal Engineer,Pharma Recipe Authoring
Nagarro · Remote · India · 6mo ago
Company Description
👋🏼We're Nagarro.
We are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale across all devices and digital mediums, and our people exist everywhere in the world (17700+ experts across 39 countries, to be exact). Our work culture is dynamic and non-hierarchical. We're looking for great new colleagues. That's where you come in!
Job Description
REQUIREMENTS
• Total experience 11+ years in Pharma Manufacturing / MES consulting
• Hands-on experience with Pharma MES platforms such as Rockwell PharmaSuite, Siemens Pharma OpCenter, Werum PAS-X, or Tulip
• Strong experience in Pharma Recipe Authoring and MBR/EBR/EMBR configuration and execution
• Experience leading end-to-end MES implementations across Assessment, Design, Build, Integration, Validation, and Rollout phases
• Strong understanding of GxP compliance, data integrity, audit trails, electronic signatures, and validation requirements
• Experience with shopfloor system integration across ISA-95 layers (L1–L5) including automation, historians, and enterprise systems
• Knowledge of ISA-95 and ISA-88 standards for manufacturing operations and recipe management
• Experience working with multiple MES platforms with a platform-agnostic consulting mindset
• Familiarity with manufacturing analytics platforms, historians, data lakes, or event streaming architectures
• Experience working with global pharma manufacturing sites, multi-language deployments, and change management initiatives
• Strong communication, collaboration, and stakeholder management skills across Operations, QA, IT, Automation, and Validation teams
• Strong solutioning and pre-sales experience including customer workshops, opportunity shaping, and value articulation
• Ability to translate business requirements into system design and technical solution architecture
RESPONSIBILITIES
• Lead end-to-end MES implementation programs for pharmaceutical manufacturing environments
• Conduct discovery workshops to identify business problems, define value cases, and shape MES opportunities
• Drive process mapping (As-Is / To-Be), gap assessments, and requirements documentation (URS / FRS)
• Design and configure Recipe Management, MBR/EBR workflows, exception handling, and Review-by-Exception processes
• Architect and guide integration between MES, automation systems, ERP, LIMS, and other enterprise systems across L1–L5 layers
• Lead cross-functional teams across functional design, system integration, validation, and deployment
• Manage project scope, risks, milestones, and stakeholder communication across global programs
• Ensure regulatory compliance alignment including GxP, audit trails, and electronic records/signatures
• Support validation deliverables including documentation, testing coordination, and regulatory readiness
• Provide solution leadership during pre-sales engagements including demonstrations, workshops, and proposal development
• Influence customer decisions through value-based solutioning and risk-aligned architectural recommendations
• Support global rollouts, hypercare support, and continuous improvement initiatives post-implementation
Qualifications
Bachelor’s or master’s degree in computer science, Information Technology, or a related fields