Clean Utilities Sr Engineer

Career Category

Engineering

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing subject matter expertise to support operations upon start up.

The Utilities System Owner reports to the Director of the Amgen North Carolina Facilities & Engineering group.

• Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
• Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
• Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.

We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a leader with these qualifications.

• High school diploma / GED and 10 years of Engineering/Maintenance experience OR
• Associate’s degree and 8 years of Engineering/Maintenance experience OR
• Bachelor’s degree and 4 years of Engineering/Maintenance experience OR
• Master’s degree and 2 years of Engineering/Maintenance experience OR
• Doctorate degree

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and…