Engineer - Drug Substance Technology & Engineering
Listed on 2026-10-20
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Engineering
Process Engineer, Quality Engineering, Manufacturing Engineer, Validation Engineer
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‑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.
What you will doLet’s do this! Let’s change the world! Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients’ lives? Amgen discovers, develops and delivers innovative human therapeutics.
A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.
Advancing science and helping patients – these dual passions are ingrained in our culture. They drive our work, our values, and everything we do staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people’s lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities, from training and education to expanding current job responsibilities.
Responsibilities include but are not limited to:
- Transfer purification drug substance processes and process improvements from the laboratory to manufacturing facilities and between manufacturing sites.
- Provide solutions to technical problems of moderate scope and complexity.
- Evaluate, select, and apply standard engineering techniques and procedures under general supervision; seek assistance when addressing unusual problems.
- Support process validation for late‑stage commercial processes.
- Provide on‑the‑floor technical support for process scale‑up and technology transfer, as well as clinical and commercial manufacturing operations.
- Perform routine and non‑routine process monitoring and troubleshooting.
- Support nonstandard shift schedules and extended hours as business needs require.
- Trend process data and perform statistical analyses.
- Provide technical input for process‑related deviations (NCs), CAPAs, and change controls.
- Identify and support process‑related operational excellence and continuous improvement opportunities, including efforts to improve efficiency across business process work streams.
- Represent Process Development and collaborate with Manufacturing, Quality, Regulatory, Research, Maintenance, Utilities, Facilities, and Validation teams to develop requirements and recommendations for process or system modifications.
- Communicate and collaborate with technical and management staff across Manufacturing, Process Development, and Quality.
- Complete assignments with clear…
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