This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours. This is a 12-month initial contract, Responsibilities 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 Writing technical reports Water sampling Testing of In Process samples such as Protein Concentration, Density & pH 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 Experience working in an aseptic cleanroom performing Environmental Monitoring Proficient in the use of LIMS & LMES 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 Demonstrated leadership and communication skills Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies Skills: Aseptic Manufacturing Microbiology Environmental Monitoring Water Sampling GMP