Senior Clean Utilities Engineer – GMP Biopharma

NCBioImpact; Holly Springs (NC); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen is seeking a Senior Engineer for Clean Utilities in North Carolina. The role partners with Facilities & Engineering to design, build, commission, and qualify systems for drug substance production, ensuring GMP compliance and continuous operations.

You will lead system ownership, support design and startup activities, develop maintenance programs, and drive improvements through data analytics and RCA. Domestic/international travel may be required.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering or related field.
• 4+ years in Biopharmaceutical operations/manufacturing environment (preferred).
• Experience with GMP Biopharmaceutical Production facility utility equipment/systems.
• Familiarity with regulatory requirements (GMP, OSHA, EPA) and change control processes.

Responsibilities

• Owns Clean and Plant Utility system performance and maintenance.
• Designs, builds, commissions, and qualifies new equipment and systems.
• Supports startup, commissioning, and qualification activities.
• Develops maintenance programs and ensures spare parts availability.
• Leads RCA and implements corrective/preventive actions.
• Supports new product/technology introductions and capital projects.
• Applies data analytics to monitor performance and reduce risks.
• Travel domestically/internationally as needed.

Skills

Analytical thinking

Communication

Leadership

Problem solving

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Doctorate degree (PhD)

10 years engineering/maintenance experience

Job description

Amgen is seeking a Senior Engineer for Clean Utilities in North Carolina. The role partners with Facilities & Engineering to design, build, commission, and qualify systems for drug substance production, ensuring GMP compliance and continuous operations.

You will lead system ownership, support design and startup activities, develop maintenance programs, and drive improvements through data analytics and RCA. Domestic/international travel may be required.