Validation Engineer

TalentBurst, an Inc 5000 company; Vacaville (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

TalentBurst is seeking a QC Equipment Qualification Specialist to support laboratory equipment qualification activities in a cGMP-compliant pharmaceutical environment. This 100% onsite role requires coordinating with lab personnel and vendors to execute protocols and maintain data integrity.

Under direct supervision, you will author and review qualification protocols, participate in continuous improvement, and ensure scheduling and prioritization align with business objectives.

Qualifications

• BS/BA degree in a scientific discipline
• Experience in the pharmaceutical/biopharmaceutical industry preferred
• Knowledge of cGMP or equivalent regulations
• Minimum of two years' experience in Validation or equipment qualification preferred

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.

Skills

Verbal communication

Written communication

Relationship building

Problem solving

Education

BS/BA degree

Job description

Job Description Job Overview

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 client 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

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.