Validation Engineer

What are we looking for in our Validation Engineer?

The Information Technology team at Russell Tobin & Associates is supporting a top Biotechnology organization that has an opening for a Validation Engineer.

Duration: 8 Months Plus

Pay Range: $55/hr - $70/hr on W2 (DOE)

Description:

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

• 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 client policies, procedures, and job descriptions.
• Provide input to technical / investigation reports.
• Identify, troubleshoot, and propose a 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.

Benefits Info

Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

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Rate/Salary: $55/hr - $70/hr