Validation Engineer I

Validation Engineer I

Location: Vacaville, CA Duration: 06 Months Shift: M-F 8am - 4pm (including unpaid lunch 30 mins) 5x onsite

Job Summary:

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 principals, 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.

Duties:

Technical:

• 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.

Job Requirements:

• BS/BA degree (preferably in relevant scientific discipline)
• Experience (may vary depending on site size/scope)
• 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 of 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