Career Category
Information Systems
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.
Validation Engineer
You will play a pivotal role in ensuring compliance across the Process Development and Manufacturing. The Validation Engineer will assist the Benchtop product team with all aspects of the computer validation process across the Operations footprint.
Role Description:
Let’s do this. Let’s change the world. In this vital role you will be part of the Benchtop Product Team working on computerized systems validations (CSV) and GAMP (Positive Automated Manufacturing Practice). This vital role ensures Amgen systems remain compliant with industry standards and comply with all regulatory requirements.
Roles & Responsibilities:
- Advising clients on how to meet compliance requirements using a risk-based approach.
- Develop validation documentation and standard operating procedures for various GxP applications.
- Develop test protocols that thoroughly test business requirements.
- Provide test execution oversight and assist with deviation recommendations as required, work with clients to