Quality Engineer, Validation

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 Quality organization at HTO comprises Quality Assurance, Quality Systems & Compliance, Quality Control, and Quality Engineering & Validation. Together, we 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 to provide quality oversight for the site qualification/validation program. You will perform quality oversight of qualification and validation activities associated with equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods. This is inclusive of technology transfer and process validation.

• You will review and approve a variety of documents to support qualification and validation activities, ensuring compliance with internal quality system requirements.
• You will provide input and quality oversight to qualification/validation exceptions/deviations.
• You will provide guidance to internal customers on best practices for executing consistent, reproducible, and compliant qualification and validation activities.
• You will exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional teams.
  
  

Who you are:

• You hold a Bachelor’s degree with 0-2 years relevant industry experience (direct validation or quality validation experience preferred).
• You have an ability to interpret procedures and guidelines and put them into practice.
• You have a strong attention to detail.
• You have the ability to make sound, science and risk-based decisions about quality and technical subjects.
• You exhibit a growth mindset and willingness to learn.
• You have flexibility in problem solving and work hours to meet business objectives.
• You are able to quickly and consistently establish rapport and collaborate effectively with team members and partners.
• Biopharmaceutical or pharmaceutical industry experience in technical validation or quality validation is preferred.
  
  

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $73,250 - $136,110. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

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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