Principal Engineer, Pharma Recipe Authoring

🕒 Março 23

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Nagarro

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1996

🤝 B2B

🏢 Corporativo

B2B • Enterprise • Technology Consulting

Nagarro é um líder global em engenharia digital e consultoria de tecnologia. A empresa ajuda os clientes a se tornarem negócios inovadores e digitais, aproveitando a tecnologia para impulsionar avanços nos negócios. Conhecido por sua agilidade empreendedora e mentalidade CARINHOSA, a Nagarro oferece uma ampla gama de serviços, incluindo engenharia digital, soluções empresariais inteligentes e serviços de experiência e design. Com mais de 17. 900 funcionários em 37 países, a Nagarro colabora com líderes do setor para acelerar a digitalização e a inovação orientada pela tecnologia.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• Employees can work remotely