Computerized Systems Validation Specialist
Job type:
Computerized systems validation expertise drives this Specialist I role, supporting data integrity, GxP compliance, and validation across manufacturing systems.The Specialist I supports validation and leads projects when required for equipment, facilities, utilities, processes, and computer systems. The work includes CSV reviews, pragmatic validation strategies, and technical guidance for quality processes. Collaboration connects IT, validation, business units, and QA decisions.Key Responsibilities:
Review and approve CSV materials for computerized system projectsApply Global GxP requirements to validation strategiesMonitor DI/CSV effectiveness and recommend optimization opportunitiesParticipate in internal and external computerized systems auditsDeliver CSV education and data integrity awarenessRequirements:
BS in Engineering, Chemistry, Microbiology, or related fieldFive to seven years of related validation experienceExpert knowledge of validation principles and conceptsStrong knowledge of CSV, GAMP, and 21 CFR Part 11Excellent communication, organization, and attention to detailApply validation leadership, CSV knowledge, and data integrity expertise across regulated computerized systems and quality processes.
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Review and approve CSV materials for computerized system projectsApply Global GxP requirements to validation strategiesMonitor DI/CSV effectiveness and recommend optimization opportunitiesParticipate in internal and external computerized systems auditsDeliver CSV education and data integrity awarenessRequirements:
BS in Engineering, Chemistry, Microbiology, or related fieldFive to seven years of related validation experienceExpert knowledge of validation principles and conceptsStrong knowledge of CSV, GAMP, and 21 CFR Part 11Excellent communication, organization, and attention to detailApply validation leadership, CSV knowledge, and data integrity expertise across regulated computerized systems and quality processes.
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Vacancy posted 3 hours ago
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