Purpose:This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.Responsibilites:****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 Density & pHRequirementsBachelors degree in a science disciplineBiopharmaceutical QC experience in a microbiology labExperience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical productsPreferred QualificationsExperience working in an aseptic cleanroom performing Environmental MonitoringProficient in the use of LIMS & LMESCompetenciesTechnically 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 agenciesShift Patterns : This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.Two shift patterns : Two days followed by Two nights - from 07:00 to 19:00 & 19:00 to 07:00.