MES System Owner

As part of the Hillsboro IT OT team, you will serve as the System Owner / Local Product Owner for the Manufacturing Execution System (MES – Rockwell PharmaSuite) in a 24x7 GMP pharmaceutical manufacturing environment. You will ensure robust system lifecycle management, GMP compliance, and support for product transfers, while contributing to global IT OT standardization and optimization.

Key Responsibilities

• Own and manage the MES system lifecycle: design, integration, maintenance, validation, and retirement.
  

• Ensure GMP compliance for system changes, upgrades, and integrations (SAP, LIMS, EDMS, etc.).
  

• Partner with business stakeholders to improve processes and enable standardized technologies across sites.
  

• Define business criticality and product quality requirements, ensuring governance, compliance, and disaster recovery.
  

• Lead vendor discussions, technical evaluations, and Agile-based delivery initiatives.
  

• Support regulatory audits and inspection readiness.
  

Qualifications

• Bachelor’s degree in Informatics, Engineering, or related field.
  

• 5+ years of experience with Manufacturing Systems (preferably Rockwell PharmaSuite).
  

• Strong background in bio-pharmaceutical or life sciences manufacturing.
  

• Proficiency in MES, ERP, LIMS, PI Data Historian, and Quality Systems (Veeva, ValGenesis).
  

• Experience with SQL Server, scripting, troubleshooting, and batch management.
  

• Solid understanding of GMP, FDA 21 CFR Part 11, cGMP Annex 11, and data integrity principles.
  

• Strong collaboration, vendor management, and Agile leadership skills.
  

• Willingness to support 24x7 on-call operations, including weekends/holidays.