Validation Engineer

Perform characterization studies and DOE's (as required).- Develop validation strategies- Write/Submit/Execute IQ (Installation Qualification) /OQ (Operational Qualification) /PQ (Performance Qualification) and TMV (Test Method Validation) protocols and submit to the document management system for approval.- Procure the required materials for validations (if required).- Coordinate the execution of validations with operations.- Software validation (as required).- Closeout validation activities.- Write Test Reports and submit in the applicable Quality Documentation Management System for approval.- Provide technical support and engineering troubleshooting as required to Operations.- Write or modify the following documents: PFD, PI, MOP, EPR, and CAL (as required).- Evaluate new Equipment as required.- Support on CAPA (Corrective Action / Preventive Action) /NCR (Non-Conforming Request) / NCC (Non-Conforming Corrections) action item activities to expedite on-time completion**Job Types**: Full-time, ContractPay: $50,000.00 - $70,000.00 per monthApplication Question(s):- How many years of knowledge of ISO13485 and GMP's (Good Manufacturing Practices) do you have?**Education**:- Bachelor's (required)**Experience**:- IQ, OQ, PQ Validations: 3 years (required)- Microsoft Office: 1 year (preferred)- Protocol Writing: 2 years (required)- Medical Device Validation: 1 year (required)**Language**:- English (required)- Spanish (preferred)Work Location: In person