Process Equipment Validation Engineer jobs in United States
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Advantage Technical · 2 days ago

Process Equipment Validation Engineer

positionAustin, TX
timeContract
remoteOnsite
senioritySenior Level
money$50/hr - $55/hr
date5+ years exp

Advantage Technical is seeking a Process Validation Engineer to support medical device manufacturing in Austin, Texas. This role focuses on equipment and process validation to ensure compliance with internal and regulatory requirements.

Staffing & Recruiting
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Lead equipment and process validation activities from planning through completion
Oversee IQ, OQ, PQ, and TMV to ensure regulatory and quality compliance
Develop, execute, and review validation documentation, including protocols, reports, risk assessments, and change controls
Ensure validation activities follow approved procedures and documentation standards
Partner with cross-functional teams on technical, quality, and continuous improvement efforts
Assess validation approaches, resolve technical issues, and recommend compliant solutions
Support facilities validation and related quality engineering initiatives as needed

Qualification

Equipment validationProcess validationRegulatory standards knowledgeStatistical analysisFacilities validation experienceCommunication skillsProblem-solving skillsIndependent work

Required

Bachelor's degree in Engineering or related field with 5–6 years of experience in medical device, pharmaceutical, or biotech manufacturing
Strong knowledge of applicable quality and regulatory standards (e.g., FDA, ISO, GAMP)
Hands-on experience with manufacturing equipment validation and statistical analysis
Ability to work independently, manage multiple priorities, and make sound technical decisions
Strong communication and problem-solving skills

Preferred

Facilities validation experience in a 24/7 manufacturing environment

Company

Advantage Technical

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Advantage Technical aligns people and companies to create opportunity.
location
Cincinnati, Ohio, USA
people-size10001+ employees
web-link
https://advantagetechnical.com/

H1B Sponsorship

Advantage Technical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)

Funding

Current Stage
Late Stage
Company data provided by crunchbase