Looking for a move to a world class medical device facility based in Sligo. Our client has a permanent requirement for a Engineer to work on validation of computers systems, equipment and software.
As a member of the validation team your main responsiblities will be:
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.
Adheres to and supports all EHS & E standards, procedures and policies
As a CSV you will need:
3rd level qualification in a relevant engineering or scientific discipline.
Minimum of 2 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.
Contact Kathy at LSC on 021 4777 329 for more details, or apply directly via this advert.