Luis Rivas

Computerized System Validation Engineer Lead Activities: o Validation experience and domain of each regulated area: MES systems, SAP, Infor, eDHR, e-signatures, Automatic and Semiautomatic manufacturing equipment’s o Create/Update CSV/CSA procedure and templates, CSVMP and CSV inventory to ensure regulatory compliance for multiples facilities, global policies and aligned GAMP5 (risk-based approach). (21 CFR Part 820 / 21 CFR Part 11 / ISO 13485 / Annex 11) o Provide support Engineering department for validation approach for automated equipment on GAMP 5, PLC, vision system. O Provide support and lead projects to implement automated equipment’s or systems, during each phase of the system life cycle. O Create, Review, Approve, CSV/CSA validation documentation as URS, risk assessment, FS, DS, MVP, Regression analysis, IQ-OQ-PQ, and reports based on risk. O Lead TMVs (gR&Rs / Agreement analysis) and process validation for automated / semiautomated equipment’s, as well as Statistical training to multiples departments o Ensure correct operation and resources for MES system (Manufacturing execution system) o Certified as Internal auditor (ISO 13485; 21 CFR 820; 21 CFR 11; MHLW; and ANVISA) R&D Sustaining Engineer Principal Activities: o Review and approve Change request. O Conduct validation & verification and stability studies. O Ensure that the design of the product are in compliant with the standards o Update DHF, PRD, Trace matrix, DFMEA for appropriated changes Knowledge: o 21 CFR Part 820 o ISO 13485 o 21 CFR Part 11 (Electronic Records and Electronics Signatures) o GMP and GAMP o Six Sigma Tools o Statistic Technics (Analysis ANOM & ANOVA, T test, F Test, Sampling plan, SPC, DOE, Cpk, Ppk, Control Charts, R&R study) Statistical Software: o Minitab (Statistics) o JMP (Statistics) Engineering Software o ProModel for Process simulation Programming language: o Delphi o Excel Spreadsheet