Nature and Scope The EMT II position in the environmental monitoring team is primarily responsible for the activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with and assists the manufacturing department and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT-II will be able to perform and oversee all activities associated with the environmental monitoring process, including sample collection of water, air, surfaces, compressed gas, and personnel. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, as well as health and safety requirements. Manage assigned daily workload to meet requirements and perform EM and PM sampling as per the schedule. Must complete and maintain gowning qualifications for support areas as well as the Aseptic Processing Area to work in clean rooms. Conduct environmental monitoring activities including sampling of air (Viable and Non-viable), compressed air and nitrogen, surface, and personnel inside the classified manufacturing areas. Conduct water sampling throughout facility. Complete incubation, transfer and final reading of samples if needed. Record results and report deviations as per specifications. Capture sampling life cycles in the LIMS software and assist with data entry for retrieval and trending from Labware LIMS. Maintain accurate records of work performed in Labware LIMS and Laboratory documentation systems according to Good Documentation Practices, Standard Operating Procedures (SOPs) and policies. Maintains compliance with all required SOPs and policies. Communicate any discrepancies or deviations to supervision/management upon discovery. Author or help data collection for assigned investigation report related to EM/PM events. Perform clean room behavior and area assessments as per procedures if needed. Review environmental and personnel monitoring sample results in Labware LIMS if needed. Performs investigations into environmental excursions and deviations under the guidance of the Environmental Monitoring Supervisor if needed. Ensures equipment and supply inventories are maintained and available for use in accordance with department needs. The EMT-II is a qualified department trainer and is expected to train and qualify EM personnel on departmental functional requirements including gowning and sampling techniques. Ensures only approved sampling materials are utilized at all times. Ensures that personnel do not perform tasks for which they do not have accurate and approved training records. Ensures that only approved documentation and procedures are utilized at all times. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Associate degree in microbiology, biology or related scientific field preferred. Minimum 3 years’ experience in environmental monitoring or equivalent experience required, preferably in the pharmaceutical /Food /medical device or Beverage industry. Experience with EMT I Duties and Responsibilities. Experience of aseptic technique. Must be able to maintain APA gown qualification for EM support. Ability to perform basic mathematical calculations. Ability to work independently and as a team with minimal supervision. Able to train other junior EMTs. Organization and attention to detail. Excellent communication skills (Oral and Written). Working knowledge of MS-Office software and PC Skills required. Good work ethic and highly motivated. Good time management skills. Ability to work in a fast-paced environment. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to work overtime, weekend and holidays as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com. Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.