Senior CQV Engineer for CIP required for Green Field site Blanchardstown Dublin
The Senior CQV Engineer will use the Risk Based Verification (RBV) approach to execute Clean in Place (CIP) commissioning and qualification activities in cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland.
As Sr. CQV Engineer you will be :
o Part of the Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel) responsible for planning of activities and ownership and closure of open issues (Punch Items, Non-Conformances etc)
o Start up and commissioning of CIP systems in a Biological and / or Pharma Environment with DeltaV automation
o Review & approve automation FDS for DeltaV (CM’s, EM’s, Graphics & Phases)
o Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
o Takes part in troubleshooting and remediation project teams.
o Field Walkdowns of systems as part of transfer of ownership of the system from Construction.
As Sr. CQV Engineer you will have:
o Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
o Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing o cility (min 2 – 5 years)
o Relevant experience as subject matter expert / engineer in a high tech industry such as Biotech or Pharma, preferable. Experience working on and knowledge of CIP systems and cleanrooms, including start up.
o Experience in using Delta V automation platform and review/approval of associated documentation essential.
o Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
For full details please contact Ruth at 021 4777329 or apply directly through this advert.