Description

The Validation Engineer will support the Site/Commercial Quality Control team at Genentech in the planning, coordination, execution, and documentation of the QC equipment lifecycle. This role involves equipment qualification, maintenance records, and ensuring compliance with GMP requirements. The successful candidate will have the opportunity to transition to a regular employee position based on demonstrated performance.

Company Culture and Environment

At Genentech, there is a strong emphasis on safety and compliance, as evidenced by their COVID-19 vaccination mandate. The workplace promotes teamwork, continuous learning, and a commitment to excellence in quality control processes.

Career Growth and Development Opportunities

Candidates demonstrating outstanding performance will have priority consideration for regular employee hiring, suggesting a clear pathway for career advancement within the organization.

Detailed Benefits and Perks

While specific benefits are not mentioned, the opportunity for professional development and potential transition to a permanent position indicates that the company values employee growth and stability.

Compensation and Benefits

• Competitive hourly compensation
• Opportunity for conversion to permanent employee status
• Potential for professional development and learning opportunities

Why you should apply for this position today

This role offers a unique chance to work at a leading biotechnology company while being at the forefront of quality control in the industry. If you are looking to grow your career in a supportive environment that values compliance and teamwork, this position is a great fit.

Skills

• Positive attitude and willingness to learn
• Strong coordination and organizational skills
• Clear and effective writing abilities
• Strong verbal communication skills
• Previous hands-on experience in equipment qualification is a plus
• Familiarity with Microsoft Office and analytical instruments software
• Good organizational skills and detail-oriented mindset
• Knowledge of GMP and compliance requirements

Responsibilities

• Support team members in planning, coordination, execution, and documentation of QC equipment lifecycle
• Generate User Requirement Specifications, System Impact Assessments, and Criticality Assessments
• Perform Quality Risk Assessments
• Generate DQ/IQ/OQ/PQ protocols under limited supervision
• Execute IQ/OQ/PQ per protocols and write qualification reports
• Review qualification documents for compliance with SOPs
• Ensure application of GMP throughout operations and meet deadlines

Qualifications

• Positive attitude toward learning
• Strong communication skills (written and verbal)
• Organizational skills with attention to detail
• Hands-on experience in equipment qualification is advantageous

Education Requirements

• B.A. or B.S. degree in a relevant scientific discipline
• Equivalent combination of education and experience may be considered

Education Requirements Credential Category

• Bachelor’s degree in a relevant scientific discipline or equivalent

Experience Requirements

• Relevant experience in the field of quality control and validation preferred

Why work in Brisbane, CA

Brisbane, CA, offers a serene environment with easy access to major urban centers while maintaining a strong sense of community. Known for its beautiful parks and scenic views, it provides an attractive setting for both work and leisure, supporting a balanced lifestyle.