Validation Engineer I
Posted
Job Title: Validation Engineer I
Location: Vacaville, CA
Duration: 06 Months
Shift: M-F 8am - 4pm (including unpaid lunch 30 mins) 5x onsite
Job Summary:
Technical:
Education:
Location: Vacaville, CA
Duration: 06 Months
Shift: M-F 8am - 4pm (including unpaid lunch 30 mins) 5x onsite
Job Summary:
- With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principals, quality policies, standards and core values.
- Maintains company s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects.
Technical:
- 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 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 of priorities.
- Flexibility in problem solving, providing direction and work hours to meet business objectives.
- 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
