Career CategoryQualityJob DescriptionThis role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.Specific Job Duties: 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 & pHInitiate and/or implement changes in controlled documents.Participate in audits, initiatives, and projects that may be departmental or organizational in scope.Write protocols and perform validation and equipment qualification/verification.Introduce new techniques to the lab, including method transfers, reports, validations and protocols.Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.Approve lab resultsBasic Qualifications Bachelor's degree in a science discipline Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Preferred Qualifications Minimum three years' Biopharmaceutical QC experience in a microbiology lab, working as part of an Environmental Monitoring team who directly support manufacturing in a Grade A/B areaProficient in the use of LIMS & LMESKnowledge of related regulatory/industry considerations, compliance issues and/or scientific discoveryBiopharmaceutical QC experience in a microbiology labExperience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical productsCompetencies Technically strong background in microbiology and aseptic manufacturing Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage Flexibility – 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 problemsAuditing documentation and operation processDemonstrated ability to interact with regulatory agencies.