Senior Clean Utilities Engineer - GMP Biopharma

Amgen

Holly Springs (NC)

In loco

USD 110.000 - 160.000

Tempo pieno

22 ore fa
Candidati tra i primi

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Vantaggi offerti da questo lavoro

Competitive benefits package
Discretionary bonus
Stock-based incentives
Flexible work models where possible

Descrizione del lavoro

Amgen’s NC facilities are seeking a Senior Clean Utilities Engineer to own and optimize plant utility systems, partner with corporate engineering, and ensure GMP-compliant startup and qualification of new equipment. You will lead improvements, manage maintenance programs, and enable reliable, compliant operations at scale.

Responsibilities include system ownership for clean and plant utilities, design/startup/qualification support, and driving data-driven improvements with RCA and predictive

Competenze

  • Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering.
  • 4+ years of relevant engineering/maintenance experience in biopharmaceutical operations.
  • Experience with GMP biopharmaceutical production facilities.
  • Ability to perform data-driven problem solving.
  • Willingness to travel domestically/internationally.

Mansioni

  • Own the utilities systems and equipment for site operations.
  • Support design, startup, and qualification of new or modified systems.
  • Lead cost/benefit analyses and business cases for projects.
  • Develop maintenance programs and ensure spare parts availability.
  • Ensure safety and regulatory compliance of systems.
  • Assist commissioning/qualification per GMP requirements.
  • Analyze performance risks and implement improvements.
  • Provide root cause analysis for downtime.
  • Support new product introductions and technology deployments.
  • Advance predictive maintenance with data analytics.
  • Lead investigations of abnormal conditions.

Conoscenze

Engineering leadership
Data analytics
Root cause analysis
GMP knowledge
Troubleshooting
Capital projects
Safety compliance
Project management
Communication
Travel willingness

Formazione

Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering
Master’s degree (advantage)

Descrizione del lavoro

Amgen’s NC facilities are seeking a Senior Clean Utilities Engineer to own and optimize plant utility systems, partner with corporate engineering, and ensure GMP-compliant startup and qualification of new equipment. You will lead improvements, manage maintenance programs, and enable reliable, compliant operations at scale.

Responsibilities include system ownership for clean and plant utilities, design/startup/qualification support, and driving data-driven improvements with RCA and predictive

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