Principal Engineer, Pharma Recipe Authoring

🕒 il y a 2 mois

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Nagarro

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1996

🤝 B2B

🏢 Entreprise

B2B • Enterprise • Technology Consulting

Nagarro est un leader mondial de l'ingénierie numérique et du conseil en technologie. L'entreprise aide ses clients à devenir des entreprises innovantes et orientées numérique en exploitant la technologie pour provoquer des percées commerciales. Réputée pour sa souplesse entrepreneuriale et son esprit CARING (Attentionné), Nagarro offre une large gamme de services, y compris l'ingénierie numérique, des solutions d'entreprise intelligentes et des services de conception et d'expérience. Avec plus de 17 900 employés dans 37 pays, Nagarro collabore avec des leaders de l'industrie pour accélérer la digitalisation et l'innovation guidée par la technologie.

Description

• 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

🎯 Exigences

• 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.

🏖️ Avantages

• Employees can work remotely