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Job Title : CSV Engineer (Computer System Validation) with DeltaV
Location : Houston, TX (Onsite – as required)
Duration : Long-term Contract
Industry : Biotech / Pharmaceutical / Life Sciences
Job Summary
Role Summary
We are seeking an experienced CSV Engineer with strong Equipment and Automation validation experience to support GxP-regulated manufacturing, laboratory, and utility systems. The role focuses on validation of computerized systems embedded in or controlling equipment, ensuring compliance with FDA and global regulatory requirements.
Key Responsibilities
Lead Computer System Validation (CSV) activities for GxP equipment and automation systems
Perform validation in compliance with 21 CFR Part 11, EU Annex 11, GAMP 5
Execute and / or review IQ, OQ, PQ for equipment and computerized systems
Develop and approve validation deliverables including :
Validation Plans & Reports
URS, FS, DS
Risk Assessments (FMEA)
Traceability Matrices
Support FAT / SAT execution and documentation
Validate PLC, SCADA, DCS, MES, and laboratory instrument systems
Review and assess control logic, alarms, interlocks, and data integrity controls
Ensure validated state through change control, deviation management, and periodic reviews
Partner with Engineering, Automation, Quality, and Manufacturing teams
Support regulatory inspections and audits (FDA, MHRA, EMA)