Principal/Senior Principal, Quality Engineer Validation

F. Hoffmann-La Roche AG; Hillsboro (OR); On-site; USD 93,000 - 172,000; Full time

Benefits offered by this job

Discretionary annual bonus

Relocation benefits

Job summary

F. Hoffmann-La Roche AG seeks professionals for Hillsboro Technical Operations at either the Principal or Senior Principal level. The role focuses on qualification, validation, and quality oversight in a manufacturing environment.

Responsibilities include overseeing tech transfer, ensuring compliance with quality standards, and leading project teams. Candidates must possess a degree and significant experience in technical and quality validation.

The competitive salary range for this position varies based on qualifications and experience.

Qualifications

• 8 years of experience for Principal or 12 years for Senior Principal.
• In-depth specialist knowledge of own discipline.
• Combination product manufacturing experience preferred.

Responsibilities

• Review and approve qualification and validation documents.
• Perform quality oversight of manufacturing processes.
• Lead cross-functional project teams.

Skills

Technical validation

Quality validation

Manufacturing processes

Engineering design fundamentals

Quality systems

Education

Bachelor’s degree

Master’s degree (preferred)

Job description

Overview

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 two operations—aseptic operations and finished goods operations—producing millions of units of life‑saving medicine for patients worldwide. This role is available for both Principal and Senior Principal levels.

Responsibilities

• Apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health‑authority expectations, and industry standards, and review and approve qualification and validation documents.
• Perform quality oversight of equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.
• Provide oversight for tech transfer, new facility expansions, large construction projects, and the scale‑up/adoption of digital technology.
• Serve as a best‑practice quality resource, lead sub‑streams or participate in cross‑functional project teams, and exercise judgment on complex issues, including inter‑organizational impact.

Qualifications

• Bachelor’s degree (Master’s preferred) with 8 years of experience for Principal or 12 years for Senior Principal.
• Experience in technical validation or quality validation.
• In‑depth specialist knowledge of own discipline and broad knowledge of related disciplines.
• Recognized internally as an expert in the chosen discipline.
• Combination product manufacturing experience (single‑use autoinjector platforms) is preferred.

Compensation & Benefits

Salary range: $93,000–$172,000 (Principal) or $112,700–$209,300 (Senior Principal). Actual pay is based on experience, level, qualifications, geographic location, and other permissible factors. A discretionary annual bonus may be available. Relocation benefits are offered.

Equal Opportunity Employer

Genentech is an equal‑opportunity employer. We employ, promote, and treat all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including on the basis of protected veteran status, disability, and other protected classes. If you have a disability and need an accommodation in the online application process, please contact us by completing the Accommodations for Applicants form.