Manufacturing Principal Engineer

Role Summary

Manufacturing Principal Engineer responsible for shaping the digital transformation of manufacturing, designing the digital backbone of factories, and guiding the architectural vision and roadmap for MES/LES within a global manufacturing network.

Responsibilities

• Architectural Leadership: Design and own the architectural roadmap for enterprise-wide MES/LES platforms to support a global manufacturing network and future technologies.
• Strategic Process Optimization: Re-engineer critical manufacturing and lab processes using digital technology to improve OEE, cycle times, and data integrity.
• Technical Governance and Mentorship: Establish engineering standards and design patterns for MES/LES; mentor engineers and serve as the technical escalation point.
• Global Integration Strategy: Define integration with SAP ERP, LIMS, PLM, and Data Historians to enable end-to-end data integrity and batch genealogy.
• Validation and Compliance Strategy: Develop global validation strategy for manufacturing systems, ensuring GxP compliance and audit readiness (21 CFR Part 11, EU Annex 11).
• Influence Senior Leadership: Translate technical capabilities into business cases, demonstrating ROI and strategic value of manufacturing technologies.
• Innovation and Technology Scouting: Identify and evaluate Pharma 4.0 trends; lead PoCs to assess value for manufacturing operations.

Qualifications

• Required: Bachelor's or Master's in Engineering or related field; 8+ years of experience designing and implementing complex MES/LES solutions in pharma/biopharma/animal health manufacturing; expert knowledge of MES platforms (e.g., Werum PAS-X, Emerson Syncade, POMSnet) and EBR concepts; leadership in a regulated GxP environment; ability to develop multi-year technology roadmaps; experience mentoring engineers.
• Preferred: Knowledge of DevSecOps (CI/CD, Git, Docker/Kubernetes, Terraform); cloud experience (Azure, GCP) and related automation services; mastery of CSV principles per GAMP 5 and ASTM E2500; experience with regulatory audits; strong communication and influence skills.

Skills

• MES/LES Architecture
• Regulatory Compliance (GxP, 21 CFR Part 11, EU Annex 11)
• Digital Transformation & Smart Factory concepts
• Data Integrity & Batch Genealogy
• Mentorship & Technical Leadership
• System Integration (SAP ERP, LIMS, PLM, Data Historians)
• Validation Strategy & Compliance

Education

• Bachelor‚Äôs or Master‚Äôs degree in Engineering (Industrial, Chemical, Manufacturing, Computer Science) or related field

Additional Requirements

• Location: Global Headquarters ‚Äî Indianapolis, IN (Hybrid)
• Travel: Minimal