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Upstream CQV Engineer 1198

Leinster  

JOB DESCRIPTION

SimoTech are looking for an Upstream CQV Engineer for a project in Leinster. This role will support the commissioning & qualification activities for Single Use Bioreactor (SUB) skids and columns used for the manufacture of biological bulk drug substance (BDS) on a key client site.



Key Responsibilities

  • Manage, coordinate and guide SUB CQV execution based upon the validation plan.
  • Ensure adherence to project schedule timelines.
  • Serve as a subject-matter expert on SUB skids, and upstream related activities.
  • Author & review commissioning and qualification documents such as IOQ protocols, qualification validation protocols, summary reports risk assessments and deviations.
  • Owns 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 SUB skid-related issues.
  • Identify and implement SUB 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 Single Use Bioreactors and associated process equipment (e.g., filtration systems, Single Use Mixers and Bag Holders, etc).
  • Possess in-depth knowledge of SUB skid operation & Upstream processing in Biopharma.
  • Possess in depth knowledge of hazards associated with SUB skid start up.
  • Experience in troubleshooting and providing technical and engineering solutions for SUB-based operations and equipment in a biologics or similar processing environment.
  • Experience in automation change control.
  • Good interpersonal skills coupled with demonstrated ability to effectively work with cross functional area.
  • Ability to present and successfully defend technical and scientific approaches in both written and verbal form.


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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