CQV Engineer


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https://www.teamhorizon.ie/job-search/156-cqv-engineer/engineering/louth/job2021-06-08 10:28:441970-01-01Team Horizon
Job TypeContractor
LocationLouth
AreaLouth, IrelandLouthIrelandLouth
SectorEngineering
Start Date
AdvertiserHilda Lynn
Telephone+3539833013
Job Ref#1002072
Job Views141
Description
Senior CQV Engineer – Team Horizon

 

Our client has an exciting new opportunity. If successful, your role will be to support the commissioning & qualification activities of a large number of stainless-steel skids for the cGMP manufacture of biological bulk drug substance (BDS) at a biologic’s facility in Louth. You will also provide expertise to support the start-up into routine commercial manufacturing. The position is accountable for the timely completion of the stainless steel-related commissioning and qualification milestones.



Why you should apply:



  • You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.


  • They put their people first and live their diversity and inclusion values embracing all

    perspectives.


  • You enjoy working in a culture of learning and collaboration and making a positive impact.


 

What you will be doing:



  • Manage CQV execution based upon the site validation plan.


  • Accomplish timely delivery of the project.


  • Act as a subject-matter expert (SME) on stainless steel equipment and related activities.


  • Write and review commissioning and qualification documents


  • Owns the closure of any open issues such as FAT/SAT punches & deviations.


  • Closely manages compliance issues as they arise.


  • Adheres to safety regulations during CQV e.g., Safe Plans of Action, COHE, LOTO, etc.


  • Trouble shoot process and equipment-related issues.


  • Classify and implement improvements where feasible.


  • Assists system handover to Manufacturing.


  • Participates in internal and external audits when required


  • Temporary shift work may be required as needed


 

What you need to apply:



  • Bachelors of Science in Engineering Chemical / Process engineering or relevant science discipline is required.


  • A qualification in project management is desirable.


  • 3+ years’ experience for a CQV engineer role working in a Biologics or similar GMP environment as part of an engineering or technical services function.


  • Experience with facility start-up projects.


  • Proficiency in communicating and collaborating with stakeholders and vendors


  • Skilled at the execution of commissioning and qualification of stainless-steel vessels, and associated pipe-work.


  • Expert of buffer and media operations & processing in Biopharma.


  • Experience is commissioning and qualification of CIP skids would be a distinct advantage.


  • Extensive knowledge of CIP in a biopharmaceutical or similar environment would be a distinct advantage


  • Knowledge and experience in operating Delta V driven systems.


  • Knowledgeable regarding start up hazards associated with start up


  • Solution focussed and experience in troubleshooting


  • Skilled at in automation change control.


  • Great interpersonal and collaborative skills


  • Brilliant presentation skills


  • Excellent communication skills


  • Team leadership skills would be a distinct advantage


  • Knowledge of Buffer and Media operations within a multiproduct facility is advantageous


  • Widespread knowledge of CIP in a pharmaceutical or similar environment would be a distinct advantage


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