Sr. Computer System Validation Consulant
Location: 95% REMOTE / 5% ONSITE in San Diego
Type of position: Contract
Duration: 6++ months
- 8+ years of CSV management or team lead experience.
- Prior experience validating / writing test scripts for an ERP system is required (client runs IFS ERP), any other ERP experience is fitting.
- Experience in FDA regulated environment with strong understanding compliance issues as well as cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk-based validation.
- Will conduct computer system validation work, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables.
- Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports.
- Strong verbal and written communication skills are essential.