Job Title: Computer System Validation (CSV) Engineer
Location: Dallas, TX
Duration: Long-Term Contract
Summary:
Experienced CSV Engineer responsible for ensuring compliance, data integrity, and validation of computerized systems in regulated environments. The role focuses on maintaining GxP, FDA, and EMA compliance while supporting system qualification and lifecycle activities.
Key Responsibilities:
Develop and execute CSV deliverables per GAMP 5 and ALCOA+ principles.
Ensure compliance with data integrity, change control, and deviation management.
Author and execute Validation Plans, Risk Assessments, IQ/OQ/PQ, and Summary Reports.
Collaborate with Quality, IT, and Engineering teams for system validation and audits.
Support lifecycle management and system upgrades.
Qualifications:
Bachelor's degree in Engineering, Computer Science, or related field.
5+ years of CSV experience in pharma, biotech, or medical device industries.
Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+.
Experience with systems like LIMS, MES, ERP, and SCADA.
Excellent documentation and communication skills.
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