- 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.
- Bachelors degree (Life Science, Engineering)
- 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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Validation Engineer III - Vacaville, United States - BEPC Incorporated
Description
BEPC is actively looking for a Validation Engineer III in Vacaville, CA area
8-month contract with possible extensions
Benefits include medical, dental, vision, and life insurance
Pay Rate: $76.00-$81.00/hour.
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 and corporate principles, quality policies, standards, and core values.
Summary of Duties and Responsibilities:
Qualifications:
BEOCS
