Validation Engineer

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• With direct supervision, candidate is responsible for 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.
• Maintain 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.
• Perform any other tasks as requested by Senior Management to support QC laboratory operations.

• BS/BA degree (preferably in a 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.
• 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.
• Strong verbal and written communication skills and ability to influence at all levels.
• Capability of building trustful and effective relationships.
• Ability to think strategically and translate strategies into actionable plans.

Mid-Senior level

Contract

Pharmaceutical Manufacturing

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