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CQV Lead Engineer

  1. Ireland, West
Ireland
  1. Contract
Competitive
  1. CAPEX Projects
36572
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CQV Lead Engineer - North of Ireland - 12 Months Contract

Do you want to be part of one of the top 10 best companies to work for in Ireland? We have a superb opportunity for a Manufacturing Biotech Associates to join our client, a global pharmaceutical organisation in their new multifunctional facility.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Work within a team of Validation professionals from ‘Intern’ level to Associate Director to own and execute the Validation & PQ aspects of the project.
  • Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as SME on the process & equipment within the assigned area.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.
  • Implementing the requirements as outlined in the site & project Validation Master Plan(s).
  • Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
  • Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
  • Owning Change Management process for Equipment introduction within the assigned area for qualification / validation up to PQ stage.
  • Effective application of LeanSixSigma and Change Management tools in the Validation group by:
  • Leading by example in achieving results by using industry standard tools and processes
Desirable Experience:
  • Extensive C&Q/ QA/ QC/ Validation experience in highly regulated industry.
  • Experience in process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction. 
  • Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach
  • SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection 
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.
If this role is of interest to you, please apply now!
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