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.

Qualifications :

Bachelors or masters degree in computer science Information Technology or a related field.

Remote Work :

Yes

Employment Type :

Full-time