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Principal Manufacturing Systems Engineer

Amgen Inc

Amgen seeks a Principal Manufacturing Systems Engineer to lead large-scale operations technology projects across global manufacturing sites. The role combines program management, systems engineering, and team leadership to drive productivity through process optimization and automation in GMP-regulated environments.

Responsibilities

  • Lead large capital projects and product teams using Agile delivery within GMP manufacturing environments
  • Partner with site and global stakeholders to prioritize demand, manage backlogs, and align local and global strategy
  • Establish global standards, templates, and best practices for operations technology project design and deployment
  • Ensure solutions meet GMP compliance, data integrity, and regulatory inspection readiness requirements
  • Own the global operations technology roadmap including upgrades, standardization, and site deployments

Requirements

  • Bachelor's degree and 6 years of information systems or manufacturing process automation experience
  • Expertise in operations technology platforms such as Aveva Pi, DeltaV, Rockwell, or MES systems
  • Strong program and project management skills with Agile methodology proficiency
  • Knowledge of GAMP lifecycle, ANSI/ISA standards (S88, S95), and 21 CFR Part 11 compliance
  • Leadership experience managing cross-functional teams in GMP manufacturing environments
  • Financial management and vendor performance oversight capabilities
Vacancy posted 12 days ago
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