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/maintenance of the Validation Master Plans.
Generation/maintenance of Project Validation Plans.
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.
Adheres to and supports all EHS & E standards, procedures and policies
Availability to travel (if required) for short period or times
|Requisitos - Requirements
Qualification in a relevant engineering or scientific discipline.
Minimum of 3 year’s experience as a Validation Engineer or related role.
Demonstrated ability to operate as sole contributor with a proactive approach to responsibilities --assigned.
Demonstrated leadership skills in identifying and overcoming challenges.
Computer System Validation experience highly desirable.
Process Validation experience is required.
Knowledge on Validation of Highly Automated equipment.