Environmental Monitoring Specialist

4 days ago

Lansdale, United States American Cybersystems Full time

Job Description: Candidate is expected to work in a team atmosphere in collaboration with Supervisors, Process Engineers, and Equipment Maintenance Engineers. The selected person will support projects/programs and collaboratively resolve problems and issues through excellent communication, proactive planning, and project management skills. The select person will independently perform a range of activities including, but not limited to: Execute classified facility, utility, and aseptic processing area EM(Environmental Monitoring) Program requirements. Manage change that supports improvement to the Environmental Monitoring program and area sterility assurance. Support investigation of Environmental Monitoring events. Trend and evaluate data (e.g. Classified facility Qualification, Requalification, Performance Qualification, Microbial Isolates review, Investigation trending, Process Simulation support, etc.) Manage/maintain department EM metrics. Provide detailed analysis of metrics to SLP management for development of action plans. Use LIMS to plan Environmental Monitoring sampling tasks. Create and/or maintain Environmental Monitoring schedules, sampling locations, and area sampling maps. Create, update, review, and/or approval Standard Operating Procedures. Conduct routine Environmental Monitoring tasks, including but not limited to troubleshooting tester questions, making decision on Environmental Monitoring data review, planning facility requalification sampling, and ensuring routine reports are completed on schedule. Support Utilities Environmental Monitoring requirements, including clean gas and water sampling data trending. Review facility HEPA filtered air velocity documentation. Actively working in a multi-discipline cross functional project team environment

Responsibilities: Candidate is expected to work in a team atmosphere in collaboration with Supervisors, Process Engineers, and Equipment Maintenance Engineers. The selected person will support projects/programs and collaboratively resolve problems and issues through excellent communication, proactive planning, and project management skills. The select person will independently perform a range of activities including, but not limited to: Execute classified facility, utility, and aseptic processing area EM(Environmental Monitoring) Program requirements. Manage change that supports improvement to the Environmental Monitoring program and area sterility assurance. Support investigation of Environmental Monitoring events. Trend and evaluate data (e.g. Classified facility Qualification, Requalification, Performance Qualification, Microbial Isolates review, Investigation trending, Process Simulation support, etc.) Manage/maintain department EM metrics. Provide detailed analysis of metrics to SLP management for development of action plans. Use LIMS to plan Environmental Monitoring sampling tasks. Create and/or maintain Environmental Monitoring schedules, sampling locations, and area sampling maps. Create, update, review, and/or approval Standard Operating Procedures. Conduct routine Environmental Monitoring tasks, including but not limited to troubleshooting tester questions, making decision on Environmental Monitoring data review, planning facility requalification sampling, and ensuring routine reports are completed on schedule. Support Utilities Environmental Monitoring requirements, including clean gas and water sampling data trending. Review facility HEPA filtered air velocity documentation. Actively working in a multi-discipline cross functional project team environment

Qualifications: Bachelor's degree in Microbiology, Biological Sciences or Chemical Sciences/Engineering with minimum of 2 years relevant experience, or a Master's degree with 1 year of relevant experience. Required Experience: Previous experience in an EM(Environmental Monitoring) role supporting sterile, biologic, or vaccine operations, and/or proce s development activities. Previous experience in aseptic unit operations. Previous experience in a regulated environment or knowledge of cGMPs. A good understanding of the regulatory guidelines governing GMP and sterile manufacturing is important. Software: GLIMS MEDS system for Document repository Experience with MS office suite. Note: M-F, onsite role at West Point, PA. Flexible shift start time (anywhere from 7am-9am EST).

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