Sr Engineer

About Amgen

At Amgen, if you feel like you are 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.

In this vital role you will work with Amgen’s Drug Product Process Engineering team in the Drug Product Technologies organization. The role will be responsible for commercial and clinical manufacturing support in visual inspections to ensure execution excellence of new product introductions into the drug product manufacturing facility and support ongoing manufacture in Thousand Oaks. The candidate will play a key role in providing site leadership in visual inspections defect creation.

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 the creation of visual inspection defect standards to enable clinical and commercial new product introductions (NPIs) and support on‑going manufacture of parenteral drug products to Amgen’s drug product manufacturing facility in Thousand Oaks.
• Designs, implements and documents on‑site DP characterization studies, working instructions, standard operating procedures, and protocols in support / ownership of visual inspection defect creations.
• Author and/or own high‑quality technical and GMP documents.
• Ensures all aspects of all visual inspection process development supports activities adhere to required policies and procedures, including safety and training.
• Ensures that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & global standards).
• Assists in the development of any existing visual inspection program to ensure continued compliance to the necessary regulations.
• Builds and sustains excellent relationships with partner drug product teams, NPI, QA, Process Development and manufacturing teams throughout the Amgen global network to ensure alignment between program needs and site capabilities.
• Builds, maintains and improves visual inspection defect creation process.
• Provides process development expertise for visual inspections and defect creations.
• Demonstrates a deep understanding of Amgen’s drug product and primary container platforms, and supports continuous improvement.
• Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learned to deliver high‑quality manufacturing processes.
• Acts as single point of contact (POC) to Amgen network as ATO defect creation leader.

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

• Doctorate degree OR
• Masters degree and 2 years of Engineering and/or Operations experience OR
• Bachelor's Degree and 4 years of Engineering and/or Operations experience OR
• Associate's degree and 8 years of Engineering and/or Operations experience OR
• High school diploma/GED and 10 years of Engineering and/or Operations experience

• Advanced Degree in engineering, biotechnology, life sciences, or related discipline with 4+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
• Demonstrated expertise in leading functional area deliverables in visual inspections and defect creations from planning through completion, with measurable impact to business outcomes. Ability to…