Senior Quality Engineer

at  Genentech

THE POSITION

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.
This role is a crucial part of our Quality Systems and Validation team, which plays a vital role in ensuring the design, development, and qualification of equipment into GMP manufacturing and laboratory areas, analytical methods and GMP areas. As a member of this team, you will have the opportunity to work closely with various functions, drive continuous improvement, and provide oversight to ensure compliance with current GMP requirements. Your collaboration with site and corporate level functions will contribute to the resolution of quality issues and the implementation of best practices. Join our team and be a part of ensuring our equipment, systems and areas are always inspection ready.

• Provide quality oversight for site qualification and validation activities, including Computer System Validation
• Review and approve qualification documents for cGMP and technical content
• Provide technical and quality qualification assessment and approval for engineering and process changes.
• Collaborate with departments to ensure compliant and efficient execution of qualification activities
• Present and provide rationale for the qualification program during audits and regulatory inspections
• Provide input into investigations with qualification impact and collaborate on validation standards and procedure