Senior Engineer, Projects

Career Category

Engineering

Job Description

Join Amgen’s Mission of Serving Patients

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. 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.

Senior Engineer, Projects

What you will do

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 equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and qualification of equipment.
• Ensure systems are installed and operating safely and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis, investigations, and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Developing and implementing testing strategies for new and existing equipment.
• Execute qualification protocols, including commissioning qualification test protocols (CQT).
• Ensuring that all equipment adheres to industry standards and regulations.
• Analyzing and documenting test results and completing reports.
• Working closely with other members of the engineering team to troubleshoot any issues with equipment functionality.
• Conducting regular audits of equipment to ensure ongoing compliance.
• Providing training and guidance to other staff on equipment validation processes.
• Collaborating with suppliers and manufacturers to understand the operation of new equipment and its qualification requirements

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Engineering experience OR
• Associate’s degree and 10 years of Engineering experience OR
• Bachelor’s degree and 6 years of Engineering experience OR
• Master’s degree and 4 years of Engineering experience OR
• Doctorate degree and 2 years of Engineering experience

Preferred Qualifications:

• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, viral filtration, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• General knowledge of plant utilities including plant steam, heating hot water, chillers, cooling towers, air compressors, and electrical systems
• Ability to analyze problems, develop and propose engineering solutions in