Senior Clean Utilities Engineer - GMP Biopharma Operations

BioSpace

Holly Springs (NC)

On-site

USD 120,000 - 150,000

Full time

41 hours ago
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Job summary

Amgen in North Carolina is seeking a Senior Utilities Engineer to own Clean and Plant Utility systems and to partner with the corporate engineering team to design, build, commission, and qualify new equipment for drug substance production. The role requires leadership, strong troubleshooting, and GMP/compliance focus across facilities operations.

You will develop maintenance programs, ensure safety and regulatory alignment, and support engineering runs, deployments, and project capital delivery

Qualifications

  • Bachelor's degree in Chemical, Mechanical, or Electrical Engineering or equivalent.
  • Experience in Biopharmaceutical environment and GMP facilities is preferred.
  • Willingness to work 24/7 and travel domestically/internationally.

Responsibilities

  • Provide system ownership for Clean and Plant Utility systems and equipment.
  • Support design, construction, startup, commissioning and qualification of new or modified systems.
  • Develop maintenance programs and support spare parts availability.
  • Ensure safety, compliance with environmental health/safety rules, and GMP requirements.
  • Lead or support root cause analysis and corrective actions to reduce downtime.

Skills

Leadership
Communication
Problem solving
Multi-tasking
Teamwork

Education

Bachelors in Chemical/Mechanical/Electrical Eng
Masters or Doctorate (preferred)
10+ years Engineering/Maintenance exp

Tools

GMP knowledge
Reliability/RC/Root Cause Analysis
Data analytics / SPC / Six Sigma

Job description

Amgen in North Carolina is seeking a Senior Utilities Engineer to own Clean and Plant Utility systems and to partner with the corporate engineering team to design, build, commission, and qualify new equipment for drug substance production. The role requires leadership, strong troubleshooting, and GMP/compliance focus across facilities operations.

You will develop maintenance programs, ensure safety and regulatory alignment, and support engineering runs, deployments, and project capital delivery

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