Validation engineer s San Francisco CA pra

4 weeks ago


South San Francisco, United States CareerBuilder Full time

Validation Engineer

>

> Location: South San Francisco, CA Onsite

>

> Contract Duration: 5 Months

>

> Visa: Any (Except OPT & CPTs)

>

> C2C

>

> JOB DESCRIPTION::Duties

>

> * Important: Genentech has mandated COVID-19 vaccination for their

> workforce, effective

> * October 1st, 2021. All external personnel providing services to

> Genentech are required to

> * comply with this requirement.

> * Site/Commercial Quality Control at Genentech is seeking an

> associate to support team

> * members in the planning, coordination, execution, and documentation

> of the QC equipment

> * lifecycle.

> * The person is also responsible for equipment qualification and

> maintenance records.

> * The successful candidate who has demonstrated outstanding

> performance will have priority to be considered for regular employee

> hiring should a position open.

>

> Job Duties/Responsibilities:

>

> * Provide support to team members in the planning, coordination,

> execution, and documentation of QC equipment lifecycle in compliance

> with GMP requirements.

> * Progressing to generation of User Requirement Specifications,

> System Impact

> * Assessments, and Criticality Assessments.

> * Perform Quality Risk Assessments.

> * Generate DQ/IQ/OQ/PQ protocols under limited supervision.

> * Execute IQ/OQ/PQ per protocols and write qualification reports.

> * Review qualification documents to ensure compliance to SOPs.

> * Assure and apply GMP throughout operations. Meet schedules,

> timelines, deadlines.

>

> Skills and Qualification:

>

> * A positive attitude and willingness to learn new concepts and new

> work knowledge required. Strong coordination and organization skill.

> * Ability to write clearly and effectively.

> * Strong verbal communication skills. Previous hands-on experience in

> * equipment qualification is a plus. Working knowledge of Microsoft

> office as well as software

> * used in analytical and bioanalytical instruments. Good

> organizational skills and detail

> * oriented. Capable of completing assigned responsibilities within

> deadlines and keeping

> * manager informed of status. Familiarity with GMP requirements and

> compliance, particularly

> * good documentation practices.

>

> Education :

>

> * B.A. or B.S. degree (preferably in relevant scientific discipline)

> or an equivalent combination of education and experience.

>

> ------**-------

>

> Thanks & Regards ?

>

> Prashanth

#J-18808-Ljbffr



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