Clean Utilities Engineer – GMP Biopharma Operations

Amgen SA; Holly Springs, Northern (NC, KY); Hybrid; USD 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

Stock-based incentives

Retirement plan

Flexible work models

Zusammenfassung

Amgen in North Carolina is hiring a Clean Utilities Engineer to provide daily engineering support for site utility systems. You will report to the Senior Manager of the Process Engineering group and lead or support engineering projects across design, startup, qualification, and maintenance.

The role requires a strong background in chemical or mechanical engineering, GMP knowledge, and the ability to operate in a 24/7 environment while collaborating with manufacturing, QA, and validation teams to

Qualifikationen

• Bachelor’s degree in chemical or mechanical engineering with 2+ years in biopharmaceutical ops.
• Experience with GMP biopharmaceutical production facility utility equipment.
• Ability to operate in a regulated GMP environment and work in a team.

Aufgaben

• Provide system ownership for site utility systems and equipment.
• Support design, construction, startup, commissioning of new or modified systems.
• Lead or support improvements to equipment and facility systems with business case if needed.
• Develop maintenance programs and coordinate spare parts to ensure availability.
• Ensure safety and GMP compliance for systems and commissioning activities.
• Perform root cause analysis and implement corrective actions to reduce downtime.
• Assist with new product introductions by evaluating equipment modifications.
• Collaborate with manufacturing, QA, validation, and other groups on improvements.

Kenntnisse

Leadership

Technical writing

Communication

Teamwork

Analytical thinking

Problem solving

Ausbildung

Bachelor’s degree in Chemical or Mechanical Engineering

Master’s degree

Tools

Process control systems knowledge

GMP compliance

Jobbeschreibung

Amgen in North Carolina is hiring a Clean Utilities Engineer to provide daily engineering support for site utility systems. You will report to the Senior Manager of the Process Engineering group and lead or support engineering projects across design, startup, qualification, and maintenance.

The role requires a strong background in chemical or mechanical engineering, GMP knowledge, and the ability to operate in a 24/7 environment while collaborating with manufacturing, QA, and validation teams to