Laboratory Equipment Qualification Specialist

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence to help deliver new and innovative medicines for treating a wide range of diseases. The company specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Location: Vacaville, CA - 95688
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite

About the Role

With direct supervision, the Laboratory Equipment Qualification Specialist / Validation Engineer is responsible for supporting and executing QC laboratory equipment qualification activities while ensuring full compliance with current cGMP regulations and corporate principles, quality policies, standards, and core values. This role helps maintain the company’s right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.

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 policies, procedures, and job descriptions.
• Perform any other tasks as requested by Senior Management to support QC laboratory operations.

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.

Skills

• Ability to make sound decisions about scheduling and managing priorities.
• Flexibility in problem-solving, providing direction, and work hours to meet business objectives.
• 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.