Manufacturing Execution Systems Specialist

Amgen Australia Pty Ltd

Base: $107,545.40 - $145,502.60 usd; bonus/equity:...
Körber pas-x ebr design and development
Mes validation in gmp environment
Drug product manufacturing process knowledge
This role serves as a Manufacturing Execution System Subject Matter Expert supporting the B20 Drug Product manufacturing organization at Amgen

Job Summary

  • This role serves as a Manufacturing Execution System Subject Matter Expert supporting the B20 Drug Product manufacturing organization at Amgen.
  • The position involves designing, developing, and validating Electronic Batch Records to ensure reliable, compliant, and efficient manufacturing processes.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, stock-based incentives, and flexible work models.

Matching Summary

This role serves as a Manufacturing Execution System Subject Matter Expert supporting the B20 Drug Product manufacturing organization at Amgen.

Salary

Base: $107,545.40 - $145,502.60 USD; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible time-off

Skills & Requirements

Must-have

  • Körber PAS-X EBR design and development
  • MES validation in GMP environment
  • Drug Product manufacturing process knowledge
  • System integration with SAP and DeltaV
  • Electronic Batch Record lifecycle management

Nice-to-have

  • Strong technical writing and communication skills
  • Experience supporting New Product Introductions
  • Ability to manage multiple priorities in fast-paced environment
  • Cross-functional collaboration with Quality and Engineering
  • Continuous improvement of MES usability and performance

Key Requirements

  • Master's degree plus 2 years MES experience OR Bachelor's plus 4 years
  • Hands-on experience with Körber PAS-X
  • Experience with MES validation and lifecycle management in GMP
  • Familiarity with quality systems like change control and CAPA

Work Rights

Not specified

Tailored Resume

Cover Letter