Job Description
Job Title : Validation Engineer II
Location : Vacaville, CA (Onsite)
Schedule : Monday – Friday, 8 : 00 AM – 4 : 00 PM (5x onsite)
Pay Rate : $50–$62 / hr (W2)
Job Summary
Under direct supervision, the Validation Engineer II supports and executes QC laboratory equipment qualification activities in full compliance with current cGMP regulations and Roche / Genentech corporate principles, quality policies, standards, and core values . This role helps maintain the company’s operational readiness, supply reliability, and cost-effectiveness while contributing to continuous improvement initiatives .
Key Responsibilities
Technical Responsibilities :
- Perform qualification of laboratory equipment in accordance with Equipment Qualification (EQ) policies, plans, and procedures.
- Collaborate with laboratory personnel to define qualification requirements.
- Author, review, and execute equipment qualification protocols.
- Coordinate equipment qualification activities with vendors and cross-functional support teams .
- Identify and address business, quality, and compliance gaps .
- Sign documents for activities as authorized under Genentech policies, procedures, and job descriptions .
- Perform other duties as assigned by Senior Management to support QC laboratory operations.
Qualifications & Experience
Education :Bachelor’s degree (BS / BA) in a scientific or engineering discipline preferred.Experience :Minimum 2 years of experience in Validation or Equipment Qualification within the pharmaceutical or biopharmaceutical industry , or an equivalent combination of education and experience.Strong understanding of cGMP regulations or equivalent quality standards.Proven ability to schedule, prioritize, and make sound decisions in a dynamic environment.Demonstrated flexibility in problem-solving, providing direction, and adapting work hours to meet business needs.Core Competencies
Excellent verbal and written communication skills; able to influence across all organizational levels.Builds trustful and effective relationships across departments.Thinks strategically and translates strategies into actionable plans.Takes ownership , drives results, and consistently achieves expected outcomes.Work Environment & Safety
Standard office and laboratory environment .Must adhere to all safety and compliance regulations while supporting a culture of quality.