Principal Quality Validation Engineer

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 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

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 will develop new approaches to complex problems potentially influencing others to change their point of view and leading others to solve the problem through coaching conversations.

• 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 participates in global/large 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 works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.

• You will exercises judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.

Who you are:

• You hold a Bachelors degree with 8 years industry experience or Masters with 5 plus years

• Industry experience preferably in technical validation or quality validation

• You have an in-depth specialist knowledge of own job discipline and broad knowledge of related disciplines in the field

• Recognized internally as an expert in own job discipline. Has deep skills and expertise across multiple disciplines in the field.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $88,000 - $163,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Link to Roche/Genentech Benefits

Relocation benefits are available for this position.

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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