Senior Manufacturing Systems Engineer – Manufacturing Systems And Integrated Technologies

Amgen Australia Pty Ltd

Unknown, Unknown, Australia
Base: $147,421.00 - $177,467.00 usd annually; bonu...
Manufacturing execution system (mes) management
Gxp computerized system validation
Root cause analysis and capa
This role drives the operation and integration of cutting-edge manufacturing systems to serve patients living with serious illnesses

Job Summary

  • This role drives the operation and integration of cutting-edge manufacturing systems to serve patients living with serious illnesses.
  • The successful candidate will manage the MES platform and associated integrations while leading global standardization efforts across Amgen manufacturing locations.
  • Candidates must ensure compliance by maintaining inspection readiness for critical applications including data integrity, security, and SDLC validation.

Matching Summary

This role drives the operation and integration of cutting-edge manufacturing systems to serve patients living with serious illnesses.

Salary

Base: $147,421.00 - $177,467.00 USD annually; Bonus: Discretionary annual bonus program; Benefits: Comprehensive health, retirement, stock incentives, and flexible work models

Skills & Requirements

Must-have

  • Manufacturing Execution System (MES) management
  • GxP computerized system validation
  • Root cause analysis and CAPA
  • Instrument Data Acquisition (IDA)
  • PI Data Historian support
  • Regulatory inspection readiness

Nice-to-have

  • Amgen Technology Systems experience
  • CDOCS and Application Lifecycle Management
  • Artificial Intelligence applications
  • Global stakeholder collaboration
  • Multi-system competency training
  • Cyber resiliency initiatives

Key Requirements

  • Master's degree plus 2 years IS/Systems Engineering OR Bachelor's plus 4 years
  • 5+ years experience in biotech/pharmaceutical industry
  • Experience with GxP computer systems in regulated environment
  • Strong database skills including queries and stored procedures
  • Experience leading IS change control process

Work Rights

Not specified

Tailored Resume

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