
Principal Quality Validation Engineer
Welcome to Genentech, a leading biotechnology company dedicated to developing life-changing medicines for patients around the world. We are currently seeking a highly skilled and experienced Principal Quality Validation Engineer to join our team. This is an exciting opportunity to play a critical role in ensuring the quality and safety of our products through the validation of our manufacturing processes. As a key member of our Quality team, you will have the opportunity to make a significant impact on our company's mission to improve patient lives. If you are passionate about quality and have the expertise to lead validation activities, we encourage you to apply for this vital role.
- Develop and implement validation strategies for manufacturing processes to ensure compliance with industry standards and regulations.
- Lead and manage validation projects, including writing protocols, coordinating testing, and reviewing validation reports.
- Conduct risk assessments and identify areas for improvement in manufacturing processes.
- Collaborate with cross-functional teams to ensure validation activities are integrated into project timelines.
- Stay up-to-date on industry trends and regulations related to validation and implement changes as needed.
- Train and mentor junior validation engineers and provide guidance on best practices.
- Support regulatory inspections and audits by providing relevant documentation and participating in discussions.
- Investigate and troubleshoot any validation-related issues, implementing corrective and preventative actions as necessary.
- Work closely with manufacturing and quality teams to ensure products meet quality standards and are safe for patients.
- Continuously evaluate and improve validation processes to increase efficiency and effectiveness.
- Provide regular updates to management on validation activities, timelines, and any potential issues.
- Maintain all validation documentation and ensure it is organized and easily accessible for audits and inspections.
Extensive Experience In Leading And Managing Validation Activities For Pharmaceutical Products, Preferably In A Gmp Environment.
In-Depth Knowledge Of Fda And Other Regulatory Requirements Related To Validation, Including Current Industry Trends And Best Practices.
Strong Understanding Of Quality Systems, Including Risk Management And Change Control Processes.
Proven Track Record Of Successfully Implementing And Maintaining Validation Programs, Including Developing Validation Plans, Protocols, And Reports.
Excellent Communication And Collaboration Skills, With The Ability To Effectively Interact With Cross-Functional Teams And External Stakeholders.
Risk Management
Quality Assurance
Process Improvement
Project Management
Data Analysis
Root Cause Analysis
Team Leadership
Regulatory compliance
Documentation management
Gmp Standards
Validation Strategies
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Principal Quality Validation Engineer in Hillsboro, OR, USA is $115,000 - $150,000 per year. However, this can vary based on factors such as experience, education, and the specific company and industry the engineer is working in.
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Genentech, Inc., is a biotechnology corporation which became a subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche. As of February 2020, Genentech employed 13,638 people.

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