2025 Summer Intern - Validation Engineering

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, Fill/Finish and Finished Goods, which combine to produce millions of units of life-saving medicine every year to patients around the world.

The Validation Engineering role is part of our PLaNT organization. PLaNT Engineering is accountable for performing activities such as Cycle Development (CD), Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV) and Process Validation (PV) in support of technology transfer and new technology introduction to the HTO site. Validation closely collaborates across the site and occasionally works with other network organizations. Key focuses of the Validation team is right first time execution and continuous improvement efforts. As part of the Validation Engineering team, the individual in this role will have the opportunity participate in a variety of initiatives and projects to address business challenges and unmet needs that apply across the organization. This is a hands-on role and the successful candidate will be comfortable working in an agile environment and is capable of applying technical skills with creative problem solving.

This internship position is located in Hillsboro, Oregon (on site)

The Opportunity

Prior to your start date, a specific project will be identified for you that will provide you with a technical challenge, opportunity to develop further capability in the pharma/biotech space. This project will be of important business need to the Validation Engineering department, requiring an engineering solution. You will be the owner of this project and be provided with necessary supporting information, process understanding, and Subject Matter Expert contacts to enable your learning and development of a novel solution. Additionally, for further exposure and development opportunities, responsibilities while in the Validation Engineering Internship may include:

• Observe and engage with detailed project plans and timelines for the execution of CD/IQ/OQ/PQ/CV/PV/RV activities.

• Support preparation of change control documentation, including protocols, summary reports, etc., for all activities.

• Ensuring new systems are implemented within predetermined timelines and financial forecasts.

• Present and provide rationale for the completed work during periodic audits and Health Authority inspections.

• Coordinate and perform tactical activities, including coordinating with cross-functional support teams, retrieving data and results, completing documentation, as required per protocols

• Support change management system for new processes, equipment, utilities and facilities.

• Engage with cross-functional and multi-site teams.

• Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production.

• Utilize Lean Production System elements and methods to continuously improve Engineering tactical business processes and procedures.

Program Highlights

• Intensive 12-weeks , full time (40 hours per week) paid internship.

• Program start dates are in May/June (Summer)

• A stipend, based on location, will be provided to help alleviate costs associated with the internship.

• Ownership of challenging and impactful business-critical projects.

• Work with some of the most talented people in the biotechnology industry.

Who You Are

• Pursuing a Bachelor or Master degree in Engineering, Pharmaceutical Sciences, Biochemistry, or related field.

• You have a fundamental, working knowledge of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in pharmaceutical production.

• You are a strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance

• Excellent written and verbal communication skills along with a strong desire to work in multifunctional teams.

• Results-oriented, diligent and has a sense of urgency. Assertive, responsible for his/her own (self-directed) work, and is willing to commit to deadlines.

• Experience in supporting and optimizing manufacturing operations and associated processes

• Able to understand various data structures and common methods in data transformation.

• Strong analytical thinking, result-oriented team player and ability to prioritize and organize work effectively.

The expected salary range for this position based on the primary location of Hillsboro is $22-$35 hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.

Relocation benefits are not available for this job posting.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.