Validation Engineer - Vacaville, United States - BEPC Inc. - Business Excellence Professional Consulting

BEPC Inc. - Business Excellence Professional Consulting Vacaville, United States

6 days ago

Description

BEPC is hiring a Validation Engineer (Medical Device Industry) in Vacaville CA

Location: 1000 New Horizons Way Vacaville CA 95688 United States

W2 - 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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