Principal/Senior Principal, Quality Engineer Validation

Roche • Hillsboro, OR

2d • $93,000 - $209,300

About 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 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 and have good knowledge of own Quality function You will work independently within broad guidelines and policies, with guidance in only the most complex situations You will serve as a best practices/quality resource on highly significant matters relating to policies, programs, capabilities, and long-range goals and objectives. You will lead sub streams or participate in cross-functional project teams to solve complex problems by using analytical thinking, tools and judgment to identify innovative solutions for Roche (or an identified area within the company) You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact. You will exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.

Requirements

• Bachelor's degree (Masters Preferred) with 8 years (Principal) or 12 years (Senior Principal) industry experience
• Industry experience in technical validation or quality validation
• In-depth specialist knowledge of own job discipline and broad knowledge of related disciplines in the field
• Recognized internally as an expert in your own job discipline. Has deep skills and expertise across multiple disciplines in the field.

Nice To Haves

• Combination Product Manufacturing Experience (single-use autoinjector platforms)

Responsibilities

• 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.
• Perform quality oversight of the equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.
• Tech transfer oversight, new facility expansions and large construction projects and the scale up/adoption of digital technology.
• Serve as a best practices/quality resource on highly significant matters relating to policies, programs, capabilities, and long-range goals and objectives.
• Lead sub streams or participate in cross-functional project teams to solve complex problems by using analytical thinking, tools and judgment to identify innovative solutions for Roche (or an identified area within the company)
• Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.
• Exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees