Validation Engineer
Vacaville, CA - USA
Job Summary
Schedule: Monday Friday 8:00 AM 4:00 PM (includes a 30-minute unpaid lunch)
Location: 100% Onsite (5x/week)
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 client corporate principles quality policies standards and core values. Maintains the companys 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 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 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.
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.
Standard office environment
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Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Required Experience:
IC