CQV Engineer with DeltaV and Bio experience is required by a biopharmaceutical company based in West Dublin. The companiy is 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 use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities in a cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland. The role is a contract position as part of the CQV team.
The CQV Engineer will:
-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)
-To have a detailed knowledge of specific Bio-Process and Clean Utility unit operations
-Draft and review CQV test documentation.
-Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines
-Input into the core aspects of Operations SOP’s.
The CQV Engineer must have:
-Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 2 – 5 years)
-Experience in using DeltaV automation platform and review/approval of associated documentation.
-Experience in IMB/FDA environment is advantageous.
-Strong technical writing and communication skills
-Proven track record in RFT generation of validation/verification documentation
-Problem solving and Project Management skills.
-Must be goal-oriented and able to prioritize and manage tasks
Call James at LSC on 021 477329 for more information on this new CQV role or apply directly via this advert