We are seeking an Environmental Monitoring Technician to support the monitoring and testing operations for an ISO-standard classified manufacturing plant. The ideal candidate will have hands-on experience in environmental monitoring, water sampling/testing, and operating within a GMP environment using aseptic techniques. This role involves working closely with the manufacturing team, quality control laboratory, and supporting various process validation efforts.
Key Responsibilities: Perform environmental monitoring (viable and non-viable air-borne monitoring) and related testing.
Collect and test samples of Water for Pharmaceutical Use (WPU), Water for Injection (WFI), and process gases.
Conduct microbial testing, Total Organic Carbon (TOC) analysis, and other wet chemical testing.
Utilize handheld instruments such as Climate and SMA for sampling and monitoring.
Execute plate counts, gram staining, water sampling/testing, and micro/macro testing.
Ensure the setup, organization, and day-to-day operations of the Quality Control Lab.
Monitor the lab's performance against targets and address deviations through CAPA.
Maintain accurate documentation of testing activities and laboratory maintenance.
Ensure compliance with GMP and ISO standards, supporting awareness of regulatory requirements.
Provide technical support to manufacturing operations, including troubleshooting and root cause investigations.
Assist in Process and Equipment Validation projects involving laboratory services.
Qualifications: Bachelors Degree (B.S.) in a related field or an equivalent combination of education and experience.
2-5 years of relevant experience, with a preference for experience in cleaning validation and Environmental Monitoring Performance Qualification (EMPQ).
Familiarity with GMP practices and aseptic techniques in a fast-paced environment.
Experience with trending software to track and report monitoring data.
Knowledge of departmental policies and procedures in a Quality Control lab environment.