Senior CQV Engineers for Downstream C&Q operations is required for a Green Field site in Blanchardstown Dublin for 6 month contract with LSC’s client.
The Senior CQV Engineer will use the Risk Based Verification (RBV) approach to Downstream processing/Purification commissioning and qualification activities in cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland.
As CQV Engineer you will be:
-Participate in a CQV Team with key emphasis on:
-Membership of Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel)
-Planning of Own Activities
-Ownership and Closure of open issues (Punch Items, Non-Conformances etc)
-To commission Bio-Process systems with DeltaV automation
-To review & approve automation FDS for DeltaV (CM’s, EM’s, Graphics & Phases)
-Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
-Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 2 – 5 years)
-Relevant experience as subject matter expert / engineer in a high tech industry such as Biotech or Pharma, preferable.
-Experience in specific Bio-Process unit operations i.e. Liquid chromatography and / or membrane filtration operation and principles, downstream processing and CIP/SIP
-Experience in System Startup, Commissioning, Functional Testing & Qualification execution of Downstream processing systems preferred, including safe systems of work.
For full details of this role please contact Kathy on 021 4777329 or apply directly through this advert.