Senior Process Engineer - Combination Products
About the role
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. 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.
Responsibilities
Support the development and implementation of technical solutions for a variety of engineering initiatives supporting the Final Drug Product (FDP) product portfolio at Amgen network facilities.
Manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, and/or processes.
Lead the Technology Transfer process for product to the Amgen network facilities and support in the design for manufacturability of Amgen Final Drug Products.
Provide technical operations support for the continuous improvement of device assembly, packaging lines capacity and performance, and advisory of technical improvement projects.
Ensure effective communication throughout the Amgen commercial site network with all stakeholders and deliver on technical improvements.
Act as the subject matter expert lead for FDP products to Amgen network facilities.
Provide technical expertise for new process equipment and technology.
Identify the required expertise to resolve process challenges as needed.
Support the delivery of productivity, throughput and general capacity improvements across Amgen network facilities by analyzing, designing, and implementing manufacturing and business process improvements.
Engage a network of FDP expertise across the Amgen commercial and clinical operations for product (device) assembly, label and packaging.
Leverage this network in support of the technical transfer process, design for manufacturability of new combination products, performance trending of existing combination products, equipment standardization and troubleshooting/process improvements.
Requirements
Doctorate degree OR Master’s degree and 2 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Associate’s degree and 8 years of Engineering experience OR High school diploma / GED and 10 years of Engineering
Preferred Qualifications
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.
Strong teamwork, excellent interpersonal and communication skills.
Direct experience with medical devices/combination products and associated manufacturing process.
Experience of working with equipment suppliers and contract manufacturers.
Ability to work in a highly regulated and ever-changing industry.
Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
An Operational Excellence approach to work product – driving rapid results.
Process and Equipment experience.
A passion to deliver excellent work product, develop others with an infective positive attitude!