QA Validation Engineer

Posted on: 22/11/2017
Ref: VAC-16044
 
  • Country: Ireland
  • Location: Limerick
  • Industry: Commissioning/Validation
  • Discipline: Validation Engineer
  • Employment Type: Contract
  • Duration: 52 weeks+

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Job Description

LSC have an immediate requirement for a QA Validation Specialist to qualify equipment at our start up biotech client based in Limerick.

Your responsibilities would include:
-Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
-Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ for cold temperature units; fridge, freezers, incubators, warehouses.
-Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
-Interface with Commissioning and Process Sciences teams.
-Support CIP and SIP validation programs as necessary.
-Support Management in Project delivery.

The QA Validation Specialist will have:
-Third level qualification in Science or Engineering
-5 + years’ experience in GMP QA review preferably in Biotech
-Experience qualifying fridges/freezers/incubators/cold store rooms
-Experience in temperature mapping
– Experience in Document Preparation and Execution
-Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
-Good technical knowledge of Biotech equipment and the concepts of Biotech manufacturing.
-Have Troubleshooting and analytical mind-set

Call Kathy at LSC on 021 4777329 for more information on this QA Validation Specialist role or apply directly via this advert.

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