Principal/Senior Principal, Quality Engineer Validation

Genentech; Hillsboro (OR); On-site; USD 93,000 - 172,000; Full time

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

A leading biotechnology company in Hillsboro, OR is seeking a professional experienced in technical and quality validation. You will oversee key manufacturing processes and ensure compliance with industry standards while working on complex projects. The ideal candidate should possess a Bachelor's degree with significant industry experience, preferably in combination product manufacturing. Competitive compensation is provided, along with relocation benefits and a discretionary annual bonus based on performance.

Qualifications

• 8+ years (Principal) or 12+ years (Senior Principal) in industry experience.
• Expertise in technical validation or quality validation.
• In-depth knowledge of manufacturing processes and quality systems.

Responsibilities

• Apply knowledge of qualification and validation principles in manufacturing.
• Perform quality oversight of equipment, facility, and utility systems.
• Lead sub streams or participate in cross-functional project teams.

Skills

Technical validation

Quality validation

Analytical thinking

Problem-solving

Interdisciplinary expertise

Education

Bachelor's degree (Masters Preferred)

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 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.

Who you are:

• You hold a Bachelor's degree (Masters Preferred) with 8 years (Principal) or 12 years (Senior Principal) industry experience
• You have industry experience 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
• You are recognized internally as an expert in your own job discipline. Has deep skills and expertise across multiple disciplines in the field.
• Combination Product Manufacturing Experience (single‑use autoinjector platforms) is preferred.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $93,000 - $172,000 (Principal) or $112,700 - $209,300 (Senior Principal). 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.

Benefits

Relocation benefits are available for this position.

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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