CQV Engineer – Downstream

Posted on: 08/12/2017
Ref: VAC-16120
 
  • Country: Ireland
  • Location: Dublin
  • Industry: Commissioning/Validation
  • Discipline: C&Q Engineer
  • Employment Type: Contract
  • Duration: 43 weeks+

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Job Description

Senior CQV Engineers for Downstream C&Q operations is required for a Green Field site in Blanchardstown Dublin for 10 month contract.

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)

Requirements:
-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.
-Have a detailed knowledge of, and 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 on this role please contact Antoinette on 021 4777329 or apply directly through this advert.

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