Principal Engineer - Combination Product Operations MSAT Primary Container Engineering​/SRE

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.

Let’s do this! Let’s change the world!

In this vital role you will act as a cross-functional leader in Combination Product Operations (CPO) and work with internal and external teams to support the commercialization of Amgen products around the globe.

• Lead technical coordination with key primary component suppliers

• Lead primary component improvement projects related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals

• Development and management of Integrated Project Plans and program dashboards/communications

• Determine User Requirement Specifications of primary container closure systems for new and existing Amgen products

• Support integration of primary containers into new and existing devices/combination products

• Support on-going Deviation/CAPA and Change Control processes

• Support development of characterization methods for mechanical and physical properties of primary components

• Collaborate extensively with internal and external project teams, i.e. manufacturing, vendors, quality, regulatory, etc.

• Develop and share best practices and tools

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

• High school diploma / GED and 12 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR

• Associate’s degree and 10 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR

• Bachelor’s degree and 6 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR

• Master’s degree and 4 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR

• Doctorate degree and 2 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry

• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.

• Proven track record of leading and executing cross-functional projects

• Direct experience with the manufacturing process and material science of primary packaging components (glass/elastomers/polymers) for medical (aseptic) applications

• An Operational Excellence approach to work, driving rapid results

• A passion to deliver excellent work results

• Broad understanding of Combination Product Design Controls and regulatory requirements on a global scale

• Program and project management skills including:

• Strategic planning, execution and prioritization - integrating people/processes to achieve high performance, with detailed tracking of progress

• Proactive risk assessment,…