Validation Engineer

Job Summary

With direct supervision, the candidate is responsible for supporting and executing 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 company’s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects.

• 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 authorized and described by Genentech policies, procedures and job descriptions.
• Perform any other tasks requested by Senior Management to support QC laboratory operations.

• BS/BA degree (preferably in relevant scientific discipline)
• Experience (may vary depending on site size/scope)
• Experience in the pharmaceutical or biopharmaceutical industry or an equivalent combination of education and experience.
• Knowledge of cGMP or equivalent regulations.
• A minimum of two years’ experience in Validation or equipment qualification is desired.
• Ability to make sound decisions regarding scheduling and managing priorities.
• Flexibility in problem solving, providing direction and work hours to meet business objectives.

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

Standard office environment.