Associate Principal Engineer, Pharma Receipt Authoring

• Total experience 12+ years
• Experience in Pharma Manufacturing / MES consulting.
• Strong hands-on experience in Pharma MES platforms such as Rockwell PharmaSuite, Siemens Opcenter, PAS-X, or Tulip.
• Expertise in Pharma Recipe Authoring, MBR/EBR/EMBR setup, execution workflows, exception handling, review-by-exception, and e-signatures.
• Strong understanding of Pharma 4.0 concepts, ISA-95 / ISA-88 standards, and shopfloor digitalization.
• Experience in end-to-end MES implementations including Assessment, Design, Build/Configuration, Integration, Validation, Rollout, and Hypercare.
• Proven experience in shopfloor integration across L1 to L5 systems, including historians, automation systems, ERP, and enterprise applications.
• Strong experience in process mapping (As-Is / To-Be), gap assessment, URS/FRS preparation, and solution blueprinting.
• Experience in compliance-driven environments with knowledge of GxP, data integrity, audit trails, validation, and electronic signatures.
• Strong stakeholder management skills working with Operations, QA, IT, Automation, and Validation teams.
• Experience leading global MES rollouts across multiple manufacturing sites and managing multilingual deployments.
• Exposure to manufacturing analytics, cloud/data platforms, historians, event streams, and data lakes is preferred.
• Excellent communication, collaboration, presentation, and customer-facing consulting skills.
• Ability to lead customer workshops, solution discussions, and pre-sales engagements.
• Flexible to travel for domestic and international customer workshops as required.

RESPONSIBILITIES:

• Lead end-to-end Pharma MES implementation programs across the complete project lifecycle.
• Conduct discovery workshops, understand customer manufacturing processes, and define target operating models.
• Translate business and shopfloor requirements into MES functional and technical solution designs.
• Lead recipe authoring activities including MBR/EBR configuration, execution flows, exception handling, and review-by-exception processes.
• Drive process mapping, fit-gap analysis, URS/FRS documentation, and solution blueprint preparation.
• Architect and guide integrations between MES, ERP, automation systems, historians, and enterprise platforms across L1-L5 layers.
• Collaborate with cross-functional teams including QA, Manufacturing Operations, Validation, IT, and Automation stakeholders.
• Ensure compliance alignment with GxP, audit trails, e-signatures, validation requirements, and data integrity standards.
• Lead workstreams and mentor teams across functional, integration, and validation tracks.
• Manage project scope, risks, milestones, estimations, stakeholder communication, and delivery governance.
• Support UAT, validation execution, deployment planning, production rollout, and hypercare activities.
• Participate in customer presentations, solutioning discussions, and pre-sales activities to shape opportunities and influence decisions.
• Provide strategic recommendations and solution trade-offs aligned with customer value, scalability, and compliance objectives.
• Drive continuous improvement initiatives and support troubleshooting/resolution of complex MES and integration issues.

 

 

 

 

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