Department: Facility ServicesEmployment Type: Full TimeLocation: SudairDescriptionInitiates the of EM related Standard Operating Procedures (SOPs).Performs environmental monitoring sampling according to established Standard Operating Procedures, as well as generating trend data from test results.Analyzing and reading Environmental Monitoring (EM) platesWriting risk assessments and validation/requalification reportsConducting investigations, deviations, change controls.Compliant with cGMP and all regulatory guidelines and perform microbial analyses by aseptic techniques.Support daily EM laboratory operations and process/equipment qualification activities as necessary.Assist with the initiation of investigations/deviations and the determination of root causes analysis.Perform Aseptic gowning qualifications and participate in aseptic process simulations.initiating, reviewing, tracking of EM of Microbiology results in support of product release. In conjunction with Quality Assurance, ensure timely completion and data review of routine and batch-related microbiological data.Assist with facility qualification and validation as required.Perform routine and investigational environmental monitoring of classified manufacturing, filling, and support areas, as well as operation personnel monitoring. Support daily EM laboratory operations.Participate in hazardous waste training. Transfer of hazardous waste between lab and trash accumulation area/storage.Creating an evaluation program (or protocol) for microbial contamination (control parameters, sampling plan, and sampling sites).Establishing mandatory training for operators on proper cleanroom garb and practices for aseptic processesPerform additional duties as required and assigned by the EM specialistSkills, Knowledge And ExpertiseMicrobiology background or degreeFlexibility to work in shifts, including evenings, nights, weekends, and holidays, as required by production schedules.Experience in validation.Working knowledge of microbiology techniques, safety and quality and computer systems0 - 3 years' experience in a manufacturing environment. Experience in microbiology laboratory is preferred.