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

With direct supervision, the candidate is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principles, quality policies, standards, and core values. Maintains the company's right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.

Technical 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.

Requirements

• BS/BA degree (preferably in a relevant scientific discipline).
• Experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience.
• Knowledge of cGMP or equivalent regulations.
• Minimum of two years' experience in Validation or equipment qualification is desired.
• Ability to make sound decisions about scheduling and managing priorities.
• Flexibility in problem-solving, providing direction, and work hours to meet business objectives.

Knowledge / Skills / Competencies

• Possesses strong verbal and written communication skills and the ability to influence at all levels.
• Capable of building trustful and effective relationships.
• Able to think strategically and translate strategies into actionable plans.
• Takes responsibility, drives results, and achieves expected outcomes.

Work Environment / Physical Demands / Safety Considerations

• Standard office environment