CSV Engineer
Job Title: CSV Engineer
Location: Massachusetts, United States
Experience: 3 - 5 Years
Contract Duration: 12+ Months
Join a leading pharmaceutical organization and help ensure data integrity and regulatory compliance across computerized systems. We are seeking an experienced CSV Engineer to lead the validation of GxP-regulated systems, ensuring compliance with standards such as FDA 21 CFR Part 11 and EU Annex 11.
What This Role Offers-
Opportunity to contribute to high-impact capital projects
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Collaborative and inclusive team culture
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Competitive salary and comprehensive benefits package
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Plan, execute, and document the Computer System Validation (CSV) lifecycle in line with GAMP 5 and regulatory requirements
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Author and review validation deliverables including URS, risk assessments, validation plans, IQ/OQ/PQ protocols, and summary reports
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Collaborate with IT, QA, manufacturing, and system owners to ensure proper implementation and maintenance of validated systems
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Provide documentation and subject matter expertise during audits and regulatory inspections
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Manage deviations, change controls, and CAPAs related to computer systems
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Stay current with global regulatory guidelines and industry best practices for CSV
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Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or related field
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Minimum 3 years of experience in a CSV role within a GMP-regulated pharmaceutical or biotech environment
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Strong knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, and data integrity principles
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Hands-on experience with MES, LIMS, ERP, SCADA, and laboratory instrument validation (preferred)
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Excellent documentation, analytical, and communication skills
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