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.