Senior Validation Engineer

2 weeks ago

Vacaville, United States BEPC Incorporated Full time

BEPC has an open position for a Validation Engineer III in Vacaville, CA

Contract W2 Period: 8-month contract with possibilities for extensions.

Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life Insurance

This is an onsite role; candidate should be local.

Primarily responsible for the support and execution of laboratory equipment qualification and

associated computer system validation activities in compliance with current cGMP regulations. 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 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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