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Environmental Monitoring Specialist

2 months ago

SaintAubinsurGaillon, Normandie, United States SDI International Corp. Full time
Job Summary

SDI International Corp. is seeking a highly skilled Environmental Monitoring Specialist to join our team. As an Environmental Monitoring Specialist, you will be responsible for overseeing the Advanced Cellular Therapeutics Facility environmental monitoring program.

Key Responsibilities
  • Establish and maintain a facility environmental monitoring program, working with third-party vendors as references and developing processes to implement a sustainable program.
  • Develop a strategy for environmental monitoring and its execution, gathering data and feedback from stakeholders.
  • Conduct testing, review results, and analyze trending data to identify areas for improvement.
  • Create and maintain technical documents that support the program and ensure they are followed by educating technicians on aseptic techniques and gowning qualifications.
  • Track and trend environmental monitoring, investigate environmental occurrences, and assist in review of contamination events.
  • Provide continuous reporting on the status of the environment and any developing trends.
  • Work independently with minimal oversight to identify environmental causes for concern and develop corrective actions to improve processes.
Requirements
  • Knowledge of Microsoft Office software (Word, Excel, PowerPoint)
  • Knowledge of Good Manufacturing Practices and how they are utilized in an academic manufacturing environment.
  • Bachelor's Degree required.
  • Three-year experience working in a GMP facility.
Position Principal Functions% EffortDescription60Implement and maintain Environmental Monitoring (EM) program, including:Execute EM Testing in support of manufacturing processesWork with third-party vendors to assist in the development of an Environmental Monitoring program.Creation of a baseline study to understand the environment of the facility.Work with QC Specialist - Equipment to ensure cleanrooms are qualified within the required timeframe.Oversee Gowning Qualifications.Investigate any EM excursions and develop CAPAs to improve EM results.Trend EM results as needed.Develop strategy to maintain Environmental Monitoring either within the facility or with the help of 3rd-party vendors.Work with cleaning team and review environment-cleaning practices and ensure vendor cleaning meets site requirements.Schedule EM monitoring of rooms for static and dynamic testing and ensure adherence to schedule.Train staff and assess competencies on appropriate aseptic techniques.Develop, schedule, and maintain media fill simulations to support clinical activities as needed.Assist in the creation, modification, and revisions of Policies, Standard Operating Procedures, forms, worksheets, and job aids as applicable.15Assist in investigations and deviations and completion of Corrective and Preventative Actions (CAPAs) to correct gaps or improve processes and oversee quality improvement projects for environmental monitoring processes.10Provide EM testing to support validations as needed.5Provide scheduled training to facility employees in regard to best practices around aseptic technique, gowning practices, and cleanroom personnel qualifications.5Complete regular cross-training on QC testing and provide support to complete testing when the primary QC employee is unavailable.5Complete 5 hours of continuous GMP education a year.