CQV Engineer

Posted on: 11/05/2018
Ref: VAC-16498
 
  • Country: Ireland
  • Location: Dublin
  • Industry: Commissioning/Validation
  • Discipline: C&Q Engineer
  • Employment Type: Contract
  • Duration: 53 weeks

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Job Description

Validation Engineer required to join the LSC team on site with our multinational biopharmaceutical client based in Dun Laoghaire, Dublin.

As a commissioning and validation engineer you will be responsible for working within a cross functional team to ensure that the validation activities associated with process equipment for vial and syringe fill finish processes meets system requirements and recognised international standards.

As Validation Engineer your responsibilities will include:

o Assist in development of Validation Plans and development of Installation Verification, Functional Testing and Performance Qualifications (PQs) for equipment.
o Working with the team to ensure all aspects of activity within the commissioning and Validation of equipment adhere to required policies and procedures, including safety and training
o Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
o Prepare and execute validation protocols and can complete risk assessments from a quality system perspective.
o Assist with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), DQ
o Assist in the implementation of any existing Validation program to ensure continued compliance to the necessary regulations
o Assist in deviation and exception resolution and root cause analysis
o Participate as required in project activities

As Validation Engineer you will have:
o A third level qualification in Science, Engineering or a relevant Quality discipline.
o A third level qualification in Science, Engineering or a relevant Quality discipline.
o Equipment and Systems Qualification Experience up to and including PQ
o Minimum 5 years experience in a similar role.

Contact Kathy at Kgillen@lsc.ie or 021 4777329 for full details on ths role or apply directly through this advert.

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