Position Details
Validation Engineer Apply
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client 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.
Job Title: Validation Engineer II
Location: Vacaville, CA, 95688
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday from 08:00 AM to 05:00 PM
Pay Rate: $35 to $50 per hour depending on experience
Summary
- The candidate is responsible for supporting and executing QC laboratory equipment qualification activities in full compliance with current cGMP regulations and Roche/Genentech corporate principles, quality policies, standards, and core values.
- Contributes to maintaining the company's right to operate, ensuring supply to patients, and supporting cost-effectiveness by actively participating in continuous improvement projects.
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 by Genentech policies and job descriptions.
- Perform any other tasks assigned by Senior Management to support QC laboratory operations.
Required Skills
- Bachelor's degree (BS/BA) in a relevant scientific discipline.
- Experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
- Minimum of two years of experience in validation or equipment qualification.
- Demonstrated experience in continuous improvement or quality system enhancement projects.
- Knowledge of cGMP or equivalent regulatory standards.
- Strong decision-making skills related to scheduling and prioritization.
- Flexibility in problem-solving, direction, and working hours to meet business objectives.
- Excellent verbal and written communication skills with the ability to influence at all levels.
- Ability to build trustful and effective relationships.
- Strategic thinking with the capability to translate strategies into actionable plans.
- Accountability and a results-driven mindset.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
