Validation Engineer jobs in United States
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Visionary Innovative Technology Solutions LLC · 5 hours ago

Validation Engineer

Visionary Innovative Technology Solutions LLC is seeking a Validation Engineer with expertise in CSV within GxP environments. The role involves conducting risk assessments and ensuring compliance with regulatory standards.

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Hiring Manager
Mayank Rathore
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Responsibilities

5+ years of hands-on CSV in GxP environments
Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports
Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+
Experience with lab instrument software

Qualification

CSV in GxP environmentsRisk assessments21 CFR Part 11CDSLIMSComputer Software AssuranceElectronic testing toolsGAMP certificationsASQ certificationsDegree in science

Required

5+ years of hands-on CSV in GxP environments
Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports
Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+
Experience with lab instrument software

Preferred

Experience with CDS, LIMS and major vendor systems
Experience with Computer Software Assurance (CSA) principles
Experience with electronic testing tools (e.g. HPQC/ALM)
GAMP or ASQ certifications
Degree in science or engineering

Company

Visionary Innovative Technology Solutions LLC

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Visionary Innovative Technology Solutions LLC (VITS) has been founded on the principle of partnering with our clients - to provide a smarter way of working.

Funding

Current Stage
Late Stage
Company data provided by crunchbase