Process Development Engineer

Career Category

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.

Process Development Engineer

What you will do

Let’s do this! Let’s change the world! As part of Amgen’s Process Development organization, Drug Product Technologies (DPT) is seeking a highly dynamic Engineer with expertise in syringe/vial filling operations to support Amgen’s clinical and commercial sterile fill-finish manufacturing site in Thousand Oaks, CA. You will play a key role in ensuring robust aseptic processing, seamless technology transfer, process characterization, validation, and continuous verification—helping bring high-quality medicines to patients worldwide.

Key Responsibilities:

Manufacturing Support

• Lead and implement characterization studies on the floor including fill recipe development for syringes and vials, process characterization, tech transfer studies, process validation, and ongoing commercial manufacturing.

• Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Address issues with drug product processing technologies and equipment.

• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement.

• Collaborate with manufacturing as well as all support functions such as engineering, quality, and drug product technologies to provide robust and coordinated support to manufacturing.

• Identifies and implements new process improvements for current and new sterile operations for increased reliability, agility and efficiency in plant operations.

• Work with multi-functional teams conducting FMEAs, risk assessments, author technical protocols, reports and CMC subsections and present findings and project status.

Aseptic DP Technology leadership

• Serve as SME in introducing new DP manufacturing technologies in the ATO site and work with global multi-functional teams for shared standard processes in technical advancements across Amgen clinical and commercial fill-finish plants.

• Drive innovations in aseptic processes, technologies and techniques, all in alignment with evolving regulatory expectations and internal quality standards, leading to continuous improvement in GMP drug product manufacturing.

• Work individually and with a team of engineers to design, implement and document primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization

• Supports expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas.

DP Network support

• Establishes strong working relationships with partner sites across DP Manufacturing network to champion the sharing of technical standards, improvement opportunities and lessons learned to deliver high-quality manufacturing processes.

• Acts as Point of Contact (POC) to drug product teams to guide/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and inspection.

What we expect of you

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

Basic Qualifications:

• Master’s degree OR

• Bachelor’s degree and 2 years of Scientific, Engineering and/or Operations experience OR

• Associate’s degree and 6 years of Scientific, Engineering and/or Operations experience OR

• High school diploma / GED and 8 years of Scientific, Engi