PM Group wish to recruit a Senior CSV Engineer to join our Bio-pharmaceutical cient based in Sligo. Excellent hourly rate on offer.
Ensure all CSV equipment is qualified in compliance with Data Integrity policies and regulatory requirements.
Investigation of software related deviations and non-conformances as part of quality team.
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 site wide validation master plans.
Generation of validation plans, protocols and final reports to cGMP standard.
Review / approval of all protocols and final reports and participation of testing and commissioning.
Management of validation change control process.
Provide technical expertise and be the site point of contact for CSV
Third level qualification in relevant engineering / science discipline
Minimum of 4 year’s experience in a similar CSV role.
Ability to demonstrated leadership and ownership qualities in all activities related to CSV.
Prior experience working in a highly regulated environment