Validation Engineer

Genentech; Oregon, Hillsboro (IL, OR); On-site; USD 80,000 - 150,000; Full time

Job summary

An established industry player is seeking a motivated individual to join their Hillsboro Technical Operations team. In this role, you will be responsible for ensuring the successful commissioning and qualification of equipment, while supporting the introduction of new technologies. Your contributions will directly impact the reliability of drug product manufacturing for patients worldwide. If you are passionate about continuous improvement and thrive in a collaborative environment, this opportunity is perfect for you. Join a forward-thinking organization that values innovation and operational excellence, and make a difference in the biotech industry.

Benefits

Relocation Assistance

Benefits Package

Qualifications

• 0-3 years of relevant experience in pharma/biotech.
• Knowledge of cGMPs and equipment qualification.

Responsibilities

• Manage project plans for equipment qualification and validation activities.
• Collaborate across the site for continuous improvement.

Skills

Project Management

Collaboration

Communication Skills

Lean Principles

Education

BSc/MS in Chemical Engineering

Experience in Pharma/Biotech

Job description

The Position

Hillsboro Technical Operations (HTO), located in Hillsboro, Oregon, is responsible for drug product & finished goods manufacturing, ensuring reliable delivery of Roche's portfolio and pipeline products. The organization is divided into two value streams that produce millions of units annually for patients worldwide.

The Opportunity:

In this role, you will be accountable for activities such as Equipment Commissioning and Qualification, Cycle Development (CD), Performance Qualification (PQ), Re-Qualification (RPQ), Cleaning Validation (CV), and Process Validation (PV), supporting technology transfer and new technology introduction at the HTO site.

• Collaborate across the site and with network organizations
• Focus on right-first-time execution and continuous improvement
• Manage project plans and timelines for CD/IQ/OQ/PQ/CV/PV activities
• Prepare change control documentation, including protocols and reports
• Ensure timely implementation of new systems within budget
• Present work during audits and inspections
• Coordinate sample collection, data retrieval, and documentation
• Lead change management for new processes, equipment, utilities, and facilities
• Promote continuous learning and stay updated on industry advancements
• Develop innovative solutions while maintaining safety, quality, and compliance
• Apply Lean principles for process improvements

Who you are:

• BSc/MS in chemical, biochemical engineering, or related field with 0-3 years of relevant experience
• Experience in pharma/biotech industry
• Knowledge of cGMPs or equivalent regulations
• Understanding of facilities, utilities, formulation, filling, packaging, and equipment qualification
• Project management skills
• Ability to collaborate with internal and external stakeholders
• Operational excellence and industrial engineering skills are advantageous
• Strong communication skills, both written and oral

The salary range for this position in Hillsboro, OR is $80,500 - $149,500, with actual pay based on experience and other factors. Benefits and relocation assistance are available. Roche/Genentech is an equal opportunity employer. For accommodations, contact us through the provided form.