Validation Engineer

Descripción del Empleo:
Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards Generation of Computerized System Validation Documents (FAT, User Requirements, System Specifications, Installation Qualifications, Test Method Validation, Procedures).
Generation of Process Validation Documentation.
Generation of validation plans, protocols and final reports to cGMP standard. Review/approval of all protocols and final reports.
Management of validation change control process.
Execute validation of highly automated equipment. Availability to travel (if required) for short period or times.
Qualifications: Qualification in a relevant engineering or sc
Requisitos:
3-5 years of experience Education- Mechanical, Electrical or Industrial Engineer