Process Owner, Aseptic Process Simulation

Job description

The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products.  The Manufacturing organization at HTO is divided into two groups, Aseptic Operations and Finished Goods,, which combine to produce millions of units of life-saving medicine every year to patients around the world.

The Opportunity

As Process Owner, Aseptic Process Simulation, you will own, develop, maintain & deploy the overarching strategy for the execution, control, and continuous improvement of aseptic process simulation (Media Fill) program at the Hillsboro Technical Operations site. This role will also act as a central partner and key technical resource within our expansive global network, and will collaborate closely with other experts and stakeholders to ensure a robust, harmonized, and compliant approach.

You will define the framework for worst-case scenarios, validation studies and evaluation criteria, and take responsibility for the methodology, planning, execution, and analysis of Media Fills. You will work closely with customers in Manufacturing and Quality Assurance to enable successful, consistent and reliable execution of all media fill activities, and also serve as the main point of contact for all relevant interfaces with Regulatory Authorities and network personnel.

• You will develop a robust, comprehensive Aseptic Process Simulation (Media Fill) strategy that includes worst-case scenarios rooted in sound, risk-based methodology.

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