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Team Horizon

CQV Engineer

Team Horizon

  • Dublin
  • Not disclosed
  • Contract
  • Updated 03/01/2018
  • Hilda Lynn
this job is expired
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Description

Team Horizon has a vacancy for a CQV Engineer. The CQV System Owner performs activities to support the Risk Based Verification (RBV) commissioning and qualification activities in the company’s cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland and subsequent validation activities.

 

The Opportunity

 

Team Horizon has a vacancy for a CQV Engineer. The CQV System Owner performs activities to support the Risk Based Verification (RBV) commissioning and qualification activities in the company’s cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland and subsequent validation activities. The role is a contract position as part of the CQV team.

 

The Role

 

  • Lead a CQV Team with key emphasis on:

  • Co-ordination of Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel)

  • Management of Weekly Activity Planning

  • Mitigation 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)

  • To have a detailed knowledge of specific Bio-Process and Clean Utility unit operations

  • Draft, review and approve CQV test documentation.

  • Accountable for scheduling, tracking, reporting and achieving project deadlines

  • Input into the core aspects of Operations, Qualification and Validation SOP's.

  • Planning and execution of all commissioning activities in adherence to site safety procedures.

  • Operate in a manner consistent with the site incident and injury free philosophy.

  • Understanding and applying industry specific compliance standards/regulations to all CQV activities.

  • First-hand experience of a Risk Based Verification CQV (ASTM E2500) project execution

  • Leading Risk assessments, root cause analysis and investigations.

  • Generation and signing off of protocols, reports, project change controls and deviations.

  • Proactively highlighting any issues around compliance.

  • Participates in internal and external audits and inspections where required.

 

The Person

 

  • Understanding and applying industry specific compliance standards/regulations to all CQV activities.

  • First-hand experience of a Risk Based Verification CQV (ASTM E2500) project execution

  • Leading Risk assessments, root cause analysis and investigations.

  • Generation and signing off of protocols, reports, project change controls and deviations.

  • Proactively highlighting any issues around compliance.

  • Participates in internal and external audits and inspections where required.

  • Technical diploma or Degree in Engineering/Life Sciences or greater preferred.

Ref: 603
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Team Horizon

Team Horizon

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