Associate Principal Engineer, Pharma Receipt Authoring

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee comprehensive Pharma MES implementation projects throughout the entire project lifecycle.

• Facilitate discovery workshops to gain insights into customer manufacturing processes and establish target operating models.

• Convert business and shopfloor requirements into functional and technical designs for MES solutions.

• Lead recipe authoring tasks, which include MBR/EBR configuration, execution flows, exception handling, and review-by-exception processes.

• Propel process mapping, fit-gap analysis, URS/FRS documentation, and the creation of solution blueprints.

• Design and oversee integrations among MES, ERP, automation systems, historians, and enterprise platforms across L1-L5 layers.

• Collaborate with cross-disciplinary teams, including QA, Manufacturing Operations, Validation, IT, and Automation stakeholders.

• Ensure adherence to compliance standards regarding GxP, audit trails, e-signatures, validation requirements, and data integrity.

• Lead workstreams and mentor teams across functional, integration, and validation domains.

• Manage project scope, risks, milestones, estimations, stakeholder communications, and delivery governance.

• Assist in UAT, validation execution, deployment planning, production rollout, and hypercare activities.

• Engage in customer presentations, solution discussions, and pre-sales activities to cultivate opportunities and influence decisions.

• Offer strategic insights and solution trade-offs that align with customer value, scalability, and compliance goals.

• Champion continuous improvement initiatives and facilitate the troubleshooting and resolution of complex MES and integration challenges.

⛳️ Requirements

• Minimum of 12 years of total experience.

• Background in Pharma Manufacturing / MES consulting.

• Extensive hands-on experience with Pharma MES platforms such as Rockwell PharmaSuite, Siemens Opcenter, PAS-X, or Tulip.

• Proficiency in Pharma Recipe Authoring, MBR/EBR/EMBR setup, execution workflows, exception handling, review-by-exception, and e-signatures.

• Solid understanding of Pharma 4.0 concepts, ISA-95 / ISA-88 standards, and shopfloor digitalization.

• Experience with end-to-end MES implementations, including Assessment, Design, Build/Configuration, Integration, Validation, Rollout, and Hypercare.

• Demonstrated experience in shopfloor integration across L1 to L5 systems, encompassing historians, automation systems, ERP, and enterprise applications.

• Strong skills in process mapping (As-Is / To-Be), gap assessment, URS/FRS preparation, and solution blueprinting.

• Familiarity with compliance-driven environments, including knowledge of GxP, data integrity, audit trails, validation, and electronic signatures.

• Exceptional stakeholder management skills, particularly when collaborating with Operations, QA, IT, Automation, and Validation teams.

• Proven experience in leading global MES rollouts across multiple manufacturing sites and managing multilingual deployments.

• Preferred exposure to manufacturing analytics, cloud/data platforms, historians, event streams, and data lakes.

• Excellent communication, collaboration, presentation, and customer-facing consulting abilities.

• Capability to lead customer workshops, solution discussions, and pre-sales engagements.

• Willingness to travel for domestic and international customer workshops as necessary.

🏝️ Benefits

• Comprehensive health insurance coverage.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.

• Supportive and collaborative work environment.