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CQV Engineer

Posted 6 days 2 hours ago by Quanta Consultancy Services Ltd

Permanent
Not Specified
Other
Roscommon, Ireland
Job Description
CQV Engineer - Ireland - Initial 12-Month Contract - Life Sciences

Our client, a global pharmaceutical company, are looking for a CQV Engineer to support the delivery their project based in Ireland.

The company has grown to become a world leader in the development, manufacture and marketing of innovative pharmaceutical products to alleviate some of the world's biggest health problems.

What you'll deliver:
  • Develop and own the Commissioning, Qualification & Validation (CQV) activities associated with your project, aligned to project schedule and GMP requirements up to Performance Qualification of all systems and equipment.
  • Act as Client C&Q Lead for the project. Throughout execution; coordinate all commissioning and qualification activities and act as single point of contact for CQV interfaces.
  • Plan and lead execution of system commissioning and qualification of equipment in accordance with project schedule and phased release of areas.
  • Oversee and coordinate Commissioning Partner and commissioning sub-contractors; manage performance against scope and programme.
  • Commissioning partner responsible for commissioning of utility and facility systems.
  • Interface with internal stakeholders including Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.
Experience required:
  • Degree qualification in Engineering, Science, related discipline or relevant experience
  • Relevant experience in pharmaceutical and GMP regulated manufacturing environments.
  • Extensive GMP experience, with demonstrable experience.
  • Proven track record of commissioning and qualification involving solid dosage process equipment installation.
  • Experience planning and delivering complex commissioning and qualification of systems.
  • Excellent stakeholder management and reporting skills; able to present to senior leadership and governance forums.
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