Evan Devaney Email & Phone Number

County Galway, Ireland

- Carrying out endotoxin and bioburden testing on various types of catheters, stents and structural heart medical devices - Experienced in writing test validation reports for new products and cleanrooms - Skilled in audit preparation for both internal and DEKRA audits - Contributed to continuous improvement and value improvement process, saving both time and money for the Microbiology department - Carrying out environmental monitoring on cleanroom and LAF hoods

Galway

Principal Duties and Responsibilities: - Testing of QC samples provided by the Production facility to ensure compliance with specifications: eg product sterility, pH, fertility, appearance, uniformity, gel strength etc. - Calibration, maintenance and operation of lab instrumentation, including: pH meter, Spiral plater, Colony counter and Turbidometer- Maintenance of controlled organisms (ATCC and NCTC strains). - Additional routine tests include; Environmental monitoring of controlled areas, process water (bio burden & conductivity), product shelf life validation, temperature monitoring of controlled areas. - Carrying out investigations on product failures and customer complaints, reporting Non-Conformities and Out of Spec Results to the Laboratory Manager, Quality Manager and Production Manager

Galway

- Endotoxin testing of endoscopy and renal dialysis waters using Kinetic Turbidimetric Method- Completion of fluid monitoring on treated waters- Carrying out Particulate Air and Total Viable Counts on clean-room air and LAF hoods - Experienced in the completion and review of documentation to GMP standards - Skilled in compressed air monitoring - Responsible for the login of samples ensuring correct tests are completed on samples- Identification of bacteria, yeasts and moulds- Skilled in aseptic technique and the aseptic transfer of bacterial cultures

Castlebar, Co Mayo

- Member of Environmental Monitoring Team where my duties include; - Carrying out Particulate Air and Total Viable Counts on clean-room air and LAF hoods - Qualifying newly installed HEPA filters by use of Particulate air counts- Performing clean-room surface monitoring with use of swabs and contact plates - Carried to completion an investigation into the recovery of total viable organisms with use of cotton swabs compared to recovery of flocked swabs on clean-room surfaces- Carried out investigation into the use of hand driers in clean rooms- Performed monitoring of incubator and refrigerator temperatures using DAS system- Currently carrying out endotoxin testing of filled units, raw materials and WFI using Kinetic Turbidimetic Method- Experienced in the review of documentation and the changing of procedures- Skilled in bioburden testing of filled units, filled units containing antibiotic, WFI and raw water- Proficient in sterility canister growth check and responsible of sterility release- Involved in Microbiology Labs 6S project- Contributor to continuous improvement initiative providing cost saving measures

- Worked as part of Technical Operations team attaining testing information from batch documents of tests carried out on chemical reagents and completion of data trending- Involved in label consolidation used a cost saving measure by Beckman Coulter- Altered Beckman Coulter’s Device Master Records in accordance with a label change on twelve different chemical reagents products - Completed my Honors degree thesis on my time in Beckman Coulter in that I made suggestions on how system can be improved

B.Sc; Applied Immunology, Applied Biology And Biopharmaceutical Science; 2007; 2002; Molecular Biology

Activities and Societies: AstroTurf soccer, golf Final Year Project Alter Device Master Record by use of EDMS to Consolidate Labels on 2L.

Education record