Process Development Engineer

Overview

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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.

Process Development Engineer

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

The Engineer will join Amgen’s Drug Product Process Engineering team in the Drug Product Technologies organization. Working with the Principal Engineer Process Validation Manager of Amgen Thousand Oaks (ATO) Process Engineering, this role will be responsible for commercial process validations to ensure execution excellence of commercial technology transfers into the drug product manufacturing facility in Thousand Oaks.

The candidate will play a key role in bringing a wide variety of high-quality licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. This role will be based in Thousand Oaks, CA. Some US or international travel may be required to support Amgen’s drug product network.

• Leads / supports new product introductions (NPI) and lifecycle changes by integrating the product’s process design and requirements with the site’s procedures and capabilities to enable commercial tech transfers of parenteral drug products to Amgen’s drug product manufacturing facility in Thousand Oaks.
• Designs, implements and documents on-site DP characterization studies in support / ownership of technology transfer & PPQ.
• Supports make-a-batch exercises to determine facility fit and identify gaps.
• Author and/or own high-quality process technology transfer and other technical documents.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable laws (FDA, EU & global standards).
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
• Be a key contributor to regulatory filings throughout the authoring, editing and submission process but also be responsible for responses to regulator questions as required, and support PAI, GMP inspections in the plant.
• Build and sustain excellent relationships with partners – drug product teams, NPI, QA, Supply Chain, Process Development and manufacturing teams to ensure alignment between program needs and site capabilities.
• Build, maintain and improve tech transfer efficiency tools, including utilization of offline characterization capabilities and predictive models, development of templated documents, implementation of lessons learned and more.
• Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of deviations.
• Demonstrate a deep understanding of Amgen’s drug product and primary container platforms, and support continuous evolution of platforms for agile tech transfers & improved manufacturability.
• Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical…