Principal Engineer,Pharma Recipe Authoring

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

Bachelor’s or master’s degree in computer science, Information Technology, or a related fields

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