Computer System Validation Specialist jobs in United States
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Jobs via Dice ยท 2 hours ago

Computer System Validation Specialist

Dice is the leading career destination for tech experts, and they are seeking a Computer System Validation Specialist for their client, IO Associates. This role is essential for driving strategic initiatives in digital technology and quality management systems, ensuring that computerized systems meet compliance and operational standards.

Computer Software
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Responsibilities

Contribute to risk assessments and management processes
Support Quality Management System (QMS) functions, including Deviations, Change Control, and CAPA activities
Author, review, and contribute to User Requirements, Configuration, and Functional Specifications
Develop and execute Qualification protocols and other testing activities
Perform lifecycle tasks such as periodic reviews, change management, and system decommissioning

Qualification

ValidationGxP quality systemsManufacturing PracticesComputer hardware/softwareEnterprise software platformsRisk managementTechnical writing

Required

Associate's degree in engineering, biology, computer science, mathematics, or a related discipline
Minimum of 2 years in a technical role (Engineering, IT, lab work), or an equivalent combination of education and experience
Experience in Validation, GxP quality systems, software quality, bio-manufacturing, or related fields
Basic understanding of Good Manufacturing Practices (GMP) regulatory requirements
Strong professional communication and technical writing skills
Proficiency with computer hardware/software for business functions

Preferred

Familiarity with computerized chemical/biological manufacturing systems, enterprise software platforms (ERP, eQMS, LIMS), or computerized analytical instruments
Demonstrated proficiency in science-based critical thinking and risk management

Company

Jobs via Dice

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Funding

Current Stage
Early Stage
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