Validation Engineer

Ellab; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

An established industry player is seeking a Validation Engineer to deliver exceptional validation consulting services. This role involves authoring and executing critical documentation, performing calibrations, and interfacing with customers to ensure all validation needs are met. You will thrive in a dynamic environment where your troubleshooting skills and technical expertise will shine. Join a supportive team that values your contributions and fosters your professional growth while working in a rewarding field focused on quality assurance in the pharmaceutical manufacturing industry.

Qualifications

• Experience in an FDA regulated industry, preferably in engineering or validation.
• Experience with Equipment Qualification is required.

Responsibilities

• Authoring and executing validation documentation including protocols and reports.
• Performing calibration and verifications for validation projects.

Skills

Excellent communication skills

Strong troubleshooting skills

Computer literacy

Education

BS in Engineering

BS in Life Sciences

Tools

Ellab software applications

Job description

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Base pay range

$65,000.00/yr - $90,000.00/yr

Greater Chicago, IL

Job Brief

The Validation Engineer shall perform validation consulting services, including but not limited to process validation and equipment qualification, protocol generation and execution, data analysis and reporting, and calibration.

The position will primarily work during normal business hours of 8 AM to 5 PM, Monday through Friday, but may require occasional off-hours and weekend work, and travel.

The goal of the Validation Engineer is to meet all customer expectations while performing field support of customer equipment.

Responsibilities

The Validation Engineer is responsible for:

• Authoring, reviewing, approving, and executing validation documentation including protocols, summary reports, procedures, and other lifecycle documents
• Performing calibration and verifications in support of validation and engineering projects
• Interfacing with customers to develop validation documentation, schedule projects, and communicate study results
• Recording and reconciling project costs and information required for final billing
• Analyzing and interpreting data from qualification studies if it meets acceptance criteria
• Troubleshooting customer and Ellab equipment
• Supporting and maintaining the validation department equipment/inventory
  
  

Requirements

• BS in Engineering or Life Sciences preferred
• Experience in an FDA regulated industry, preferably in an engineering, validation, or operations role
• Experience with Equipment Qualification is required. Experience with SIP Qualifications is preferred.
• Excellent communication skills
• Strong troubleshooting skills
• Computer literacy, including proficiency with Ellab software applications
• Must be able to lift 50 lbs

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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