Downstream System Owner

Amgen Australia Pty Ltd

Thousand Oaks, California, United States
Base: $88,281.00 - $119,439.00 usd annually; bonus...
Not specified (assumed to be onsite given the nature of the role).
Cgmp procedures and engineering practices
Downstream purification equipment knowledge
Validation protocol development and execution
Amgen Australia Pty Ltd is seeking a Downstream System Owner to support manufacturing activities at their Thousand Oaks location. The ideal candidate will have extensive experience in engineering and operations within regulated environments, particularly in the biotech or pharmaceutical sectors, and will play a critical role in ensuring equipment reliability and compliance with safety standards

Job Summary

  • The role supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks.
  • Engineers are accountable for consistent equipment performance, reliability, and driving safety and quality compliance.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, and stock-based incentives.

Matching Summary

Match Score: 85

Amgen Australia Pty Ltd is seeking a Downstream System Owner to support manufacturing activities at their Thousand Oaks location. The ideal candidate will have extensive experience in engineering and operations within regulated environments, particularly in the biotech or pharmaceutical sectors, and will play a critical role in ensuring equipment reliability and compliance with safety standards.

Salary

Base: $88,281.00 - $119,439.00 USD annually; 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

  • cGMP procedures and engineering practices
  • downstream purification equipment knowledge
  • validation protocol development and execution
  • risk-based verification experience
  • regulatory inspection defense

Nice-to-have

  • Lean Six Sigma process improvement
  • Delta V or Rockwell automation systems
  • Strong technical writing skills
  • Mentoring project teams
  • Collaborative team environment

Key Requirements

  • Master's degree OR Bachelor's with 2 years experience
  • 7+ years relevant work experience preferred
  • Direct experience with FDA/OSHA/EPA regulated environments
  • Experience in operations/manufacturing environment

Work Rights

Not specified

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