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.
The CQV Engineer will be responsible for:
o Supporting validation actions for Packaging and Warehousing facility, and temperature mapping of various units / areas.
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 systems and facilities.
o To co-ordinate and execute validation activity for new product introduction, or changes to secondary packaging processes.
o Performing data analysis and determine conclusions reached.
o Attends departmental and team meetings focused on CQV activities
o Understanding and applying industry specific compliance standards/regulations to all Commissioning/Qualification activities with focus on ASTM E2500, Eudralex and FDA standards.
The CQV Engineer will require:
o Technical diploma or 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 position, then please contact Kathy at LSC on 021-4777329 or apply directly through this advert.