Manufacturing Principal Engineer

Role Summary

Manufacturing Principal Engineer — a technical thought leader shaping strategy for the digital transformation of manufacturing. Design the digital backbone of factories, lead the architectural vision for MES/LES, and mentor a team to drive a cutting-edge manufacturing ecosystem aligned with smart factory ambitions.

Responsibilities

• Architectural Leadership: Design and own the architectural roadmap for enterprise-wide MES/LES platforms, ensuring global scalability, regulatory compliance, and readiness for future technologies.
• Strategic Process Optimization: Re-engineer critical manufacturing and lab processes using digital technology to improve OEE, reduce cycle times, and enhance data integrity.
• Technical Governance and Mentorship: Establish engineering standards and design patterns; serve as the technical escalation point and mentor engineers.
• Global Integration Strategy: Define integration with SAP ERP, LIMS, PLM, and Data Historians to create a digital thread with end-to-end data integrity and batch genealogy.
• Validation and Compliance Strategy: Develop global validation strategy to exceed GxP standards and comply with 21 CFR Part 11 and EU Annex 11.
• Influence Senior Leadership: Translate technical capabilities into clear business cases and ROI for manufacturing technology investments.
• Innovation and Technology Scouting: Identify Pharma 4.0 trends; lead proof-of-concept projects to drive business value.

Qualifications

• Required: Bachelor's or Master's degree in Engineering or related field.
• Required Experience: 8+ years of experience designing, implementing, and managing complex MES/LES solutions in a large-scale pharmaceutical, biologics, or animal health manufacturing environment.
• MES/LES Mastery: Expertise with MES platforms (e.g., Werum PAS-X, Emerson Syncade, POMSnet) and electronic batch records.
• Pharmaceutical/GxP Leadership: Experience in regulated environments with data integrity requirements.
• Architectural and Strategic Thinking: Ability to develop multi-year roadmaps that improve cost, quality, and speed.
• Technical Mentorship and Leadership: Proven ability to mentor engineers and lead complex projects.

Preferred Qualifications

• DevSecOps: CI/CD, Git, Docker/Kubernetes, Terraform.
• Cloud Platform Proficiency: Azure and Google Cloud Platform, including automation services.
• Regulatory and Validation Expertise: CSV principles per GAMP 5 and ASTM E2500; experience with FDA/EMA/USDA audits.
• Communication and Influence: Ability to articulate vision to diverse audiences and leadership.

Additional Requirements

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