Environmental Monitoring Specialist
- To establish environmental monitoring system for our Aseptic Production area and participate in qualification/validation of personnel, machines and area based on EU & SFDA requirements.
- Establishing Environmental Monitoring system for aseptic production in SaudiBio based on EU & SFDA requirement.
- Develop and validate new methods for the detection of microorganisms in environmental monitoring.
- Developing Protocols & Reports on findings from environmental monitoring.
- Write standard operating procedures (SOPs) for all aspects of related work performed in the environmental monitoring.
- Knowledge to interpret date gathered from QC and making trends.
- Train new personnel in basic environmental monitoring techniques and SOPs.
- Perform environmental monitoring of classified cleanrooms.
- Isolate and identify microorganisms from environmental samples (personnel, air, and machine).
- Participate in facility qualification activities related to environmental monitoring.
- Assist in the development and implementation of new cleaning and sterilization processes.
- Must be able to demonstrate and apply good aseptic technique and cleanroom behavior.
- Monitor, track/trend periodically provide an EM summary report.
- Ensure ordering, receipt, and correct storage of environmental monitoring sampling tools and materials.
Qualifications & Experiences
- Bachelor’s degree in Microbiology, Biology, Chemistry
- Master’s in Microbiology is a nice to have
- 5 year of experience in Environmental Monitoring for pharmaceutical or Biological industry with EU & SFDA – GMP environment and or Multi-National EU – GMP environment experience.
- Working Knowledge of EU GMP and SFDA guidelines.
- Business-Results Orientation
- Excellent Team Development
- Expert Intercultural Sensitivity
- Good command in English Language (Verbal and Written)