Validation Engineer

Job Title: Validation Engineer
Location: Vacaville California 95688
Duration: 12 Months

JOB DESCRIPTION
Schedule: Monday – Friday, 8:00 AM – 4:00 PM (includes a 30-minute unpaid lunch)

Location: 100% Onsite (5x/week)

Job Summary
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.

Duties
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.

Job Requirements
Education
BS/BA degree (preferably in a 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 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