Specialist Manufacturing – Cleaning Validation

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. 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 do

Do you enjoy solving technical challenges in a multi‑product manufacturing environment? Are you motivated by leading complex cross‑functional projects and using data to improve systems that protect product quality and patients? If you have a passion for cleaning validation and want to contribute to Amgen’s mission to serve patients‑every patient, every time‑then check out this exciting opportunity.

The position is within Drug Substance Supply at Amgen Thousand Oaks (ATO), supporting the site’s multi‑product drug substance manufacturing operations. ATO supports products from clinical development through commercial production. The Manufacturing Programs organization works across Manufacturing, Quality, Engineering, Supply Chain, and Process Development to support new product introductions, equipment and technology changes, continuous improvement, and reliable operations.

In this vital role, the Specialist Manufacturing – Cleaning Validation will serve as a technical lead and subject matter expert for equipment cleanability and cleaning/sterilization validation within the Manufacturing Programs organization in Drug Substance Supply at Amgen Thousand Oaks (ATO).

The role owns cleaning validation requirements for new product introductions (NPIs) and existing products, including MAC/MAR calculations. As an individual contributor, the Specialist will lead complex cross‑functional projects, provide technical support to manufacturing operations, and use data to guide compliant solutions and continuous improvement. The role also supports commissioning, qualification, audits, and routine monitoring to maintain and confirm the validated state of equipment.

• Own equipment cleanability assessments and cleaning/sterilization validation requirements for new product introductions (NPIs) and existing products, including MAC/MAR assessments.
• Lead complex cross‑functional projects from scope and planning through execution and implementation, coordinating with Manufacturing, Quality, Engineering, Process Development, and Supply Chain.
• Provide technical support to manufacturing operations, including on‑floor troubleshooting, function testing, validation execution, major deviation investigation support, and implementation of corrective and preventive actions.
• Develop, execute, review, and approve cleaning characterization and validation strategies, protocols, reports, acceptance limits, and sampling plans.
• Assess cleanability and validation impacts for new products, equipment, process changes, and technologies;…