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Lead MES & Automation Systems Analyst - Biopharmaceutical Manufacturing

LonzaFairfield, California🇺🇸United States

Quick overview

SeniorityMid Senior
Employment typeFull Time
Work modeHybrid
LocationFairfield, California, United States

Job description

Lonza is seeking an Automation & MES Delivery Lead to drive design, implementation, and lifecycle management of manufacturing execution and automation systems in a regulated biopharmaceutical environment. You will lead end-to-end delivery of MES/automation solutions for drug substance and drug product facilities, translating manufacturing and quality requirements into robust digital workflows. Responsibilities include solution architecture, vendor and system integration oversight, project delivery, validation support, and continuous improvement. You will partner with operations, QA, IT, and global engineering, ensuring GxP compliance, data integrity, and high system reliability in support of safe, efficient, and scalable biopharma production.

Responsibilities

  • Lead end-to-end delivery of MES and automation solutions for biopharma manufacturing sites
  • Translate manufacturing, quality, and regulatory requirements into system designs and workflows
  • Define solution architecture and oversee integration with ERP, LIMS, and control systems
  • Coordinate vendors, internal IT, engineering, and operations for successful project execution
  • Support computer system validation, testing, and documentation in line with Gx
  • P and data integrity
  • Monitor and improve system performance, reliability, and user experience
  • Drive standardization and continuous improvement of MES/automation templates and processes
  • Ensure compliance with global and local regulations, including 21 CFR Part 11
  • Provide subject matter expertise and training to end users and project teams
  • Contribute to digitalization roadmap and technology selection for manufacturing IT/OT

Required Skills

  • Manufacturing Execution Systems (MES)
  • Automation systems (PLC/SCADA/DCS)
  • System integration and interfaces (ERP/LIMS/Delta
  • V/SAP)
  • Gx
  • P and FDA/EMA regulations
  • Computer system validation (CSV)21 CFR Part 11 and data integrity
  • Requirements gathering and process mapping
  • Project and delivery management
  • Biopharmaceutical manufacturing processes
  • Change management and continuous improvement

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