Downstream System Owner

Amgen Inc

Thousand Oaks, California, United States
Base: $88,281.00 - $119,439.00 usd annually; bonus...
Not specified
Master's degree or equivalent experience
Cgmp procedures and engineering practices
Downstream purification equipment knowledge
Amgen Inc. is seeking a Downstream System Owner to support manufacturing activities in compliance with cGMP standards at their Thousand Oaks, California facility. The ideal candidate will have extensive experience in engineering within regulated environments, particularly in biotech or pharmaceutical production processes

Job Summary

  • This role supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks to drive safety and quality compliance.
  • The engineer will lead all aspects of equipment operation and reliability while providing direct technical support for capital projects and continuous improvement initiatives.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, stock incentives, and flexible work models to support professional growth.

Matching Summary

Match Score: 85

Amgen Inc. is seeking a Downstream System Owner to support manufacturing activities in compliance with cGMP standards at their Thousand Oaks, California facility. The ideal candidate will have extensive experience in engineering within regulated environments, particularly in biotech or pharmaceutical production processes.

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

  • Master's degree or equivalent experience
  • cGMP procedures and engineering practices
  • Downstream purification equipment knowledge
  • Validation protocol development and execution
  • Risk-based verification on GMP process equipment

Nice-to-have

  • Experience with Delta V, Rockwell, and Plant Information Systems
  • Knowledge of Lean Transformation and Six Sigma methodologies
  • Strong facilitation and collaboration skills
  • Experience mentoring project teams and engineers
  • Background in combination product quality systems

Key Requirements

  • Bachelor's degree in engineering or science-related field preferred
  • 7+ years relevant work experience with 5+ in operations/manufacturing
  • Direct experience with FDA, OSHA, EPA regulated environments
  • Must be prepared to defend equipment during regulatory inspections

Work Rights

Not specified

Tailored Resume

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