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Intellectt Inc

Validation Engineer | Medical Devices

Entry-Level JobVerifiedNo experience needed

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What they do

A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.

$97,326 / year median in North Carolina

+0% projected growth

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Job Description

Validation Engineer | Medical Devices Intellectt Inc Winston-Salem, NC Job Details Contract $45 - $48 an hour 1 day ago Qualifications GMP Manufacturing facility experience Industrial equipment Manufacturing FDA regulations Full Job Description Job Description Support equipment qualification and validation activities for medical device manufacturing equipment. Develop and execute validation protocols, including IQ, OQ, and PQ. Prepare validation plans, protocols, test scripts, and final validation reports. Perform validation testing and review results to ensure compliance with established acceptance criteria. Determine appropriate sample sizes for validation studies and support statistical evaluation of validation data. Work with Engineering, Quality, and Manufacturing teams to execute qualification and validation activities. Support investigation and resolution of validation-related issues, deviations, and documentation requirements. Ensure all validation activities comply with applicable FDA, GMP, quality, and company requirements. Education & Experience Bachelor's degree in Engineering, Science, or a related technical field preferred. Strong experience in Validation Engineering, preferably within a medical device or other FDA-regulated manufacturing environment. Hands-on experience with equipment qualification, IQ/OQ/PQ, validation protocols, and sample size determination. Top Skills Equipment Qualification Validation Engineering
IQ / OQ / PQ
Sample Size Determination Validation Protocols Medical Device Manufacturing
FDA / GMP
Compliance Validation Documentation Pay:
$45.00 - $48.00 per hour Expected hours: 40.0 per week
Work Location:
In person