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, qualification of 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.

The Opportunity:

As a Senior Quality Engineer, your main accountability will be to provide quality oversight to projects focused on the design, development, and qualification of equipment into GMP manufacturing and laboratory areas. In this role, you will ensure compliance with current GMP requirements, troubleshoot and resolve quality issues, and drive continuous improvement initiatives. Additionally, you will:

• 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 procedures

Who You Are:

• You possess a Bachelor's degree in engineering or life sciences with at least 6 years of qualification experience in the pharmaceutical or biotechnology industry

• You possess a strong working knowledge of qualification engineering principles and concepts applicable to process, system performance, and regulatory requirements

• You are familiar with Risk Assessment Methodology (PHA, FMEA, FTA) and have strong knowledge of EU and US cGMPs and applicable validation guidance

• You have demonstrated experience working in a matrixed environment to achieve milestones and goals

Preferred:

• Laboratory design and start-up experience

• Experience in the design, build, and deploy phases for both automation and execution systems (Delta V/SCADA, Syncade, MES, BAS, EBR, Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment

Relocation is not approved for this position.

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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.