This 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 Cleanrooms Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators Reading of Environmental Monitoring Plates Bioburden testing of water & disinfectants Water sampling Testing of In Process samples such as pH Initiate and/or implement changes in controlled documents. Participate in audits, initiatives, and projects that may be departmental or organizational in scope. Basic Qualifications Bachelors 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 Experience working in an aseptic cleanroom performing Environmental Monitoring Proficient in the use of LIMS & LMES Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Competencies 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 basis Problem solving skills Experience with Regulatory inspectors and interacting with inspectors desirable Demonstrated ability to work independently and deliver right first time results Works under minimal direction Work is guided by objectives of the department or assignment Follows procedures Refers to technical standards, principles, theories and precedents as needed May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.