Validation Engineer - Vacaville, United States - BEPC Incorporated

BEPC Incorporated Vacaville, United States

3 weeks ago

Description

BEPC is hiring a Validation Engineer (Medical Device Industry) in Vacaville CA
Location: 1000 New Horizons Way Vacaville CA 95688 United States
W- 8 month contract position with potential for extension

Pay Rate range:
$63.01- $81.56

This is an onsite role, candidate should be local.

No C2C

Description:
Primarily responsible for the support and execution of laboratory equipment qualification and
associated computer system validation activities in compliance with current cGMP regulations
and Roche/Genentech corporate principles, quality policies, standards, and core values. You will
work closely with instrument vendors, facilities, IT and lab personnel to coordinate the,
installation and the qualification including computer system validation, of QC Equipment.
Reader.

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.

Coordinate equipment maintenance activities with vendors and other support

groups, as required.

Identify business, quality, and compliance gaps and propose and implement

potential improvements to systems and procedures

Sign documents for activities as authorized and described by Genentech policies,

procedures and job descriptions.

Provide input to technical / investigation reports.
Identify, troubleshoot, and propose resolution to technical problems.
Receive and provide training.
Provide input to and participate in assay transfer/validation associated with

equipment qualification/lifecycle.

Coordinate with customers to support multi-site operational activities.
Present equipment lifecycle and associated procedures/material during internal

and external audits and regulatory inspections.

Works to meet schedules and set timelines.
Perform other duties as requested by managers to support Quality activities.

Education:

Bachelors degree (Life Science, Engineering)

Experience (may vary depending on site size/scope)

Three to six years of validation experience (or equivalent experience) in a cGMP

environment with increasing levels of responsibility for a wide range of validation projects
including validation of large scale biochemical manufacturing, utility and automation
systems.

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