A CQV Engineer is required by a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
o CQV documentation – drafting, reviewing and approving CQV documentation to Regulatory standards and guidelines.
o To co-ordinate and execute Periodic Review and Requalification of Alexion systems and facilities.
o To co-ordinate and execute validation activity for new product introduction, or changes to secondary packaging processes.
o Accountable for scheduling, tracking, reporting and achieving validation deadlines.
o Input into the core aspects of Operations, Qualification and Validation SOP’s.
o Actively contribute to project teams.
The CQV Engineer will have:
o Degree in Engineering/Life Sciences or greater preferred.
o Commissioning, qualification and validation experience in GMP product manufacturing would be required (minimum of 3 years)
o Thermal mapping experience using an independent thermal mapping system
o Experience in HPRA/FDA environment advantageous.
If you would like to hear more about this CQV Engineer role, then please contact Martin at LSC on 021-4777329 or apply directly through this advert.