Validation Engineer

Sunrise Systems, Inc.; Vacaville (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Sunrise Systems, Inc. seeks a QC lab equipment qualification specialist in Vacaville, CA. Under direct supervision, you will support and execute qualification activities for laboratory equipment in compliance with cGMP and company policies.

You will coordinate with laboratory personnel, author and review qualification protocols, and work with vendors and support groups to close gaps. This on-site role emphasizes prioritization, problem solving, and strong communication.

Qualifications

• BS/BA degree in a relevant scientific discipline.
• Experience in the pharmaceutical/biopharmaceutical industry or equivalent.
• Knowledge of cGMP or equivalent regulations.
• Minimum of two years' experience in Validation or equipment qualification.
• Ability to prioritize and manage scheduling to meet objectives.

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 support groups.
• Identify business, quality, and compliance gaps.
• Sign documents for activities per Genentech policies and job descriptions.
• Support QC laboratory operations as requested by Senior Management.

Skills

Verbal communication

Written communication

Influence at all levels

Relationship building

Strategic thinking

Prioritization / time management

Education

BS/BA in a relevant science

Job description

• Schedule: Monday - Friday, 8:00 AM - 4:00 PM (includes a 30-minute unpaid lunch) 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 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 / CompetenciesPossesses 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.