QC Equipment Validation Engineer

Katalyst CRO; Vacaville (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Genentech is seeking a candidate to support and execute QC laboratory equipment qualification activities in a cGMP environment. You will work under direct supervision to ensure compliance with corporate quality standards and participate in continuous improvement projects.

The role emphasizes qualification execution, collaboration with lab personnel, and adherence to Genentech policies and job descriptions while supporting QC operations.

Qualifications

• BS/BA degree in a relevant scientific discipline or equivalent experience.
• Experience in the pharmaceutical/biopharmaceutical industry or equivalent.
• Knowledge of cGMP or equivalent regulations.
• Minimum of two years in Validation or equipment qualification preferred.
• Ability to manage priorities and make sound scheduling decisions.
• Flexible problem solving and adaptability to meet business objectives.

Responsibilities

• Perform qualification of laboratory equipment in accordance with EQ policies, plans, and procedures.
• Coordinate with laboratory personnel to define qualification requirements.
• Author, review, and execute equipment qualification protocols.
• Coordinate equipment qualification activities with vendors and other support groups.
• Identify business, quality, and compliance gaps.
• Sign documents for activities as authorized and described by Genentech policies, procedures, and job descriptions.
• Perform any other tasks as requested by Senior Management to support QC laboratory operations.

Skills

Verbal & written communication

Influence at all levels

Strategic thinking

Prioritization & decision making

Education

BS/BA degree

Job description

Genentech is seeking a candidate to support and execute QC laboratory equipment qualification activities in a cGMP environment. You will work under direct supervision to ensure compliance with corporate quality standards and participate in continuous improvement projects.

The role emphasizes qualification execution, collaboration with lab personnel, and adherence to Genentech policies and job descriptions while supporting QC operations.