Biopharma Clean Utilities Engineer – 24/7 On-Call

BioSpace

Holly Springs (NC)

On-site

USD 85,000 - 120,000

Full time

4 days ago
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Job summary

Amgen in North Carolina is seeking a Clean Utilities Engineer to provide daily engineering support for site utility systems, reporting to the Senior Manager of the Process Engineering group. The role covers design, startup, commissioning, qualification, and ongoing optimization of plant utilities.

You will develop maintenance programs, ensure safety and GMP compliance, lead root-cause analyses, and collaborate across manufacturing, maintenance, QA, and validation to drive reliable operations and

Qualifications

  • High school diploma or GED with 8 years engineering/maintenance experience
  • Associate's degree with 6 years engineering/maintenance experience
  • Bachelor's degree with 2 years engineering/maintenance experience
  • Masters degree in engineering or related field

Responsibilities

  • Provide system ownership for Utility systems and equipment at the site
  • Support design, construction, startup, commissioning and qualification of new or modified systems
  • Develop equipment/instrument maintenance programs and ensure spare parts availability
  • Ensure systems are installed and operate safely and in GMP compliance with regulatory inspectors as needed
  • Lead or support technical root cause analysis and corrective/preventive actions

Skills

Engineering principles
Maintenance
GMP knowledge
Problem solving
Team collaboration
24/7 operations readiness

Education

Masters degree
Bachelor's degree
Associate's degree
High school diploma

Tools

Process control systems
CIP/Water systems
Regulatory compliance

Job description

Amgen in North Carolina is seeking a Clean Utilities Engineer to provide daily engineering support for site utility systems, reporting to the Senior Manager of the Process Engineering group. The role covers design, startup, commissioning, qualification, and ongoing optimization of plant utilities.

You will develop maintenance programs, ensure safety and GMP compliance, lead root-cause analyses, and collaborate across manufacturing, maintenance, QA, and validation to drive reliable operations and

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