Principal Engineer,Pharma Recipe Authoring
Nagarro · Remote
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Employer requisition: REF58637Y
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Collected role description
<p>REQUIREMENTS</p><p> • Total experience 11+ years in Pharma Manufacturing / MES consulting<br> • Hands-on experience with Pharma MES platforms such as Rockwell PharmaSuite, Siemens Pharma OpCenter, Werum PAS-X, or Tulip<br> • Strong experience in Pharma Recipe Authoring and MBR/EBR/EMBR configuration and execution<br> • Experience leading end-to-end MES implementations across Assessment, Design, Build, Integration, Validation, and Rollout phases<br> • Strong understanding of GxP compliance, data integrity, audit trails, electronic signatures, and validation requirements<br> • Experience with shopfloor system integration across ISA-95 layers (L1–L5) including automation, historians, and enterprise systems<br> • Knowledge of ISA-95 and ISA-88 standards for manufacturing operations and recipe management<br> • Experience working with multiple MES platforms with a platform-agnostic consulting mindset<br> • Familiarity with manufacturing analytics platforms, historians, data lakes, or event streaming architectures<br> • Experience working with global pharma manufacturing sites, multi-language deployments, and change management initiatives<br> • Strong communication, collaboration, and stakeholder management skills across Operations, QA, IT, Automation, and Validation teams<br> • Strong solutioning and pre-sales experience including customer workshops, opportunity shaping, and value articulation<br> • Ability to translate business requirements into system design and technical solution architecture</p><p>RESPONSIBILITIES</p><p> • Lead end-to-end MES implementation programs for pharmaceutical manufacturing environments<br> • Conduct discovery workshops to identify business problems, define value cases, and shape MES opportunities<br> • Drive process mapping (As-Is / To-Be), gap assessments, and requirements documentation (URS / FRS)<br> • Design and configure Recipe Management, MBR/EBR workflows, exception handling, and Review-by-Exception processes<br> • Architect and guide integration between MES, automation systems, ERP, LIMS, and other enterprise systems across L1–L5 layers<br> • Lead cross-functional teams across functional design, system integration, validation, and deployment<br> • Manage project scope, risks, milestones, and stakeholder communication across global programs<br> • Ensure regulatory compliance alignment including GxP, audit trails, and electronic records/signatures<br> • Support validation deliverables including documentation, testing coordination, and regulatory readiness<br> • Provide solution leadership during pre-sales engagements including demonstrations, workshops, and proposal development<br> • Influence customer decisions through value-based solutioning and risk-aligned architectural recommendations<br> • Support global rollouts, hypercare support, and continuous improvement initiatives post-implementation</p>
Collected minimum qualification
<p>Bachelor’s or master’s degree in computer science, Information Technology, or a related fields</p>
Collected experience requirement
11+ years