Job DescriptionOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience on Ireland's leading aseptic manufacturing plant.This role will support manufacturing operations on a 24/7 shift pattern.Environmental Monitoring of Grade 8/9 CleanroomsEnvironmental Monitoring of Grade 5/7 Cleanrooms & IsolatorsReading of Environmental Monitoring PlatesBioburden testing of water & disinfectantsWriting technical reportsWater samplingTesting of In Process samples such as Protein Concentration, Density & pHRequirements Bachelors degree in a science disciplineBiopharmaceutical QC experience in a microbiology labExperience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical productsExperience working in an aseptic cleanroom performing Environmental MonitoringProficient in the use of LIMS & LMESTechnically strong background in microbiology and aseptic manufacturingExperience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantageFlexibility – the EM role often encounters changing priorities on a daily basisProblem solving skillsExperience with Regulatory inspectors and interacting with inspectors desirableDemonstrated ability to work independently and deliver right first time resultsWorks under minimal directionWork is guided by objectives of the department or assignmentFollows proceduresRefers to technical standards, principles, theories and precedents as neededMay set project timeframes and priorities based on project objectives and ongoing assignments.Recognizes and escalates problemsDemonstrated leadership and communication skillsAuditing documentation and operation processDemonstrated ability to interact with regulatory agenciesPackageGrad - 6 - 12 months - ca €36 - 38K per annum + 35% shift uplift2 - 3 years experience - ca €40 - 45K per annum + 35% shift uplift (ca €60K per annum)3 - 5 years experience - ca €50 - 55K per annum + 35% shift uplift (ca €75K per annum)Benefits include performance related bonus, pension, VHI for family and 23- 26 days Annual Leave + Public HolidaysShift pattern will be 2 days, 2 nights (4 days off) rolling forward 1 day each week