Validation engineer s San Francisco CA pra
4 weeks ago
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
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