Validation Engineers required for our biotech client based in Limerick to perform continuing qualification and validation activities on a start facilities. Team Lead and Team Member positions to be filled in the following areas: Clean Utilities , HVAC, CTU/Warehouse, Upstream, Downstream, CIP (may include Cleaning Validation), SIP (including Thermal/Temperature Mapping), CSV, QC Labs
As Validation Engineer you will:
o Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ protocalls, Tracematrix, Summary Report and drive post-approval of same.
o Interface with Commissioning, Process Sciences and Manufacturing teams
o Support Management in Project delivery
As Validation Engineer you will have:
o Proven BioTech experience in the given area, as follows:
o Lead position: 5 years BioTech C&Q experience, of which 2 years as a working Lead
o Team Member position: 5years BioTech experience C&Q
o Experience in Continuing Validation (re-validation or maintain a qualified state in relation to equipment/Utilities).
o Experience in gap analysis assessments
o Experienced technical writer
o Experience in Deviations/Change control writing
o Experience in continuing assessments of equipment
o Capable of managing a large program, so project management skills would be necessary
o An excellent understanding of how manufacturing/Cleaning Validation/HVAC equipment works
For full details on this role please contact Kathy on 021 4777329 or apply directly through this adver.