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Validation Engineer

Company: Ellab - Validation & Monitoring Solutions
Location: College Station
Posted on: January 17, 2022

Job Description:

We're looking for Validation Engineer with 0-4 years of experience in a cGMP environment.

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 role will involve some local business development as well as new hire training.
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
Assist in quoting of validation projects
Assist in managing delivery of validation projects
Author, review, approve and execute validation documentation including protocols, summary reports, procedures, other lifecycle documents.
Performing calibrations 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.
Analyze and interpret data from qualification studies if it meets acceptance criteria.
Troubleshooting customer and Ellab equipment.
Support and maintain the validation department equipment inventory.

Requirements
BS in Engineering, Computer Science or technical experience.
0-4 years' of experience in an FDA cGMP regulated industry, in a validation engineering role.
Experience writing and executing temperature mapping validation protocols is a plus.
CSV Experience is a plus
Project coordination experience a plus
Excellent communication skills.
Strong troubleshooting skills.
Computer literacy, including proficiency with Ellab software applications.
Must be able to lift 50 lbs.

Ellab expresses commitment to promote equality and to conduct our business according to principles of social justice, respect and freedom of expression when dealing with diversity in the workplace. Ellab shall therefore not make any distinction, exclusion or preference on the basis of age, race, color, sex, religion, political opinion, national extraction or social origin.

Keywords: Ellab - Validation & Monitoring Solutions, College Station , Validation Engineer, Engineering , College Station, Texas

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