CQV Engineer

2022-05-25 10:17:442049-11-18Team Horizon
Job TypeContractor
AreaCorkCorkIreland
SectorEngineering
Start Date
AdvertiserHilda Lynn
Telephone+3539833013
Job Ref#1002494
Job Views202
Description
2494 - CQV Engineer
 
Team Horizon is seeking an experienced Senior CQV engineer with API experience of full life cycle activities incl. doc prep, change control and protocol execution.
 
 
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:
  • The C&Q Engineer shall be responsible for carrying out the following project related activities
  • Preparation of documents associated with lifecycle of C&Q activities for a IV, FT, IQ, OQ.
  • Preparation and execution of FAT, Commissioning and SAT protocols
  • Preparation and execution of Qualification protocols (IQ and OQ)
  • Design Review (DR) and Design Qualification (DQ) protocol preparation, execution and follow-up
  • Field Walkdowns of systems as part of transfer of ownership of the system from Constructio
  • Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
  • Installation Verification execution
  • System Startup activities
  • Functional Testing of systems
  • Change Management activities during project lifecycle
  • Summary Report writing
  • Organize and review daily tasks/verifications and track the progress of the activities assigned
  • Contractors and/or Vendors coordination
  • Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End Users during the different project phases.
 
What you need to apply:
  • • A degree in science or engineering or equivalent or a certificate/diploma in similar areas with appropriate industrial experience.
  • Minimum of 5 years’ experience of C&Q activities in a large project environment within the pharmaceutical or biotech industries.
  • Hands on expertise required in one or more of the following areas: API Facilities, Isolators
  • Experience with Regulatory and industry standards for GMP and GEP
  • Self-starter & good team player
  • Good oral & written communication skills
 
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