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Downstream CQV Engineer 1194

Leinster  

JOB DESCRIPTION

SimoTech are looking for a Downstream CQV Engineer for a project in Leinster. This role will support the commissioning & qualification activities for several downstream chromatography & packing skids and columns used for the manufacture of biological bulk drug substance (BDS) on a key client site.



Key Responsibilities

  • Manage, coordinate, and guide the CQV of chromatography, packing skids and columns based upon the validation plan.
  • Ensure adherence to project schedule timelines.
  • Serve as a subject-matter expert on chromatography, packing skids and columns, and downstream related activities.
  • Author & review commissioning and qualification documents such as IOQ protocols, qualification validation protocols, summary reports, risk assessments and deviations.
  • Own the closure of any open issues such as FAT punches & deviations.
  • Proactively recognises and highlights any compliance issues as they arise.
  • Leads and maintains a safe working environment during CQV e.g., Work Permits, Safe Plans of Action, COHE, LOTO, etc.
  • Trouble shoot upstream process and chromatography, packing skids and columns related issues.
  • Identify and implement chromatography, packing skids and columns related improvements where feasible.
  • Supports system handover to manufacturing.
  • Demonstrates proficiency in communicating and collaborating with stakeholders and vendors.
  • Participates in internal and external audits when required.
  • Temporary shift work may be required as needed.


Qualifications

  • B.Eng. or B.Sc. in Chemical / Process engineering or relevant science discipline is required.
  • Experience operating in a DeltaV environment would be a distinct advantage.
  • A minimum of 3 years’ experience for downstream CQV engineer role working in a Biologics or similar GMP environment as part of an engineering or technical services function.
  • Knowledge and experience with facility start-up projects (brown field or green field).
  • Experienced in the execution of commissioning and qualification of chromatography, packing skids and columns and associated process equipment (e.g., filtration systems, single use bag holders, etc).
  • Possess in-depth knowledge of chromatography, packing skids and columns operation & downstream processing in Biopharma.
  • Possess in depth knowledge of hazards associated with chromatography, packing skids and columns start up.
  • Experience in troubleshooting and providing technical and engineering solutions for chromatography, packing skids and columns-based operations and equipment in a biologics or similar processing environment.
  • Experience in automation change control.


What SimoTech Can Offer

  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.


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