Principal/Senior Principal, Quality Engineer Validation

Job description

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 Operations organization at HTO is divided into 2 operations: aseptic operations and finished goods operations, which combine to produce millions of units of life-saving medicine every year to patients around the world. Please note there are two roles available The Opportunity: In this exciting role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards, review and approve qualification and validation documents. You will perform quality oversight of the equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods. This is inclusive of tech transfer oversight, new facility expansions and large construction projects and the scale up/adoption of digital technology. You have specialized depth and/or breadth of expertise in own specialized area an...