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Validation Engineer
Sunrise Systems Inc
🇺🇸 United States
On-site
1 month ago
1 month ago
Location: Vacaville, CA
Duration: 12 Month Contract
Position Summary
- Schedule: Monday – Friday, 8:00 AM – 4:00 PM (includes a 30-minute unpaid lunch) 100% Onsite (5x/week)
- 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 Roche/Genentech 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.
- 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.
- Education: 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.
- 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.
- Standard office environment
Validation Engineer · Sunrise Systems Inc