Description:
The Environmental Monitoring Technician plays a critical role in supporting contamination control within classified cleanroom environments. The focus of this role is to perform viable sampling along with particulate collection. This ensures compliance with cGMP and AstraZeneca’s quality standards.
The successful candidate will work as part of the Microbiology team, collaborating closely with manufacturing and quality personnel to help maintain sterile conditions and protect product integrity.
Note: This role is on-site 5 days/week.
Responsibilities
- Viable Sampling: Perform routine and event-driven viable (microbiological) monitoring of cleanroom surfaces and air, using contact plates, settle plates, and active air samplers as per established protocols.
- Particle Sampling: Conduct non-viable particulate sampling of air and surfaces in classified environments using particle counters and related equipment, ensuring all activities are thoroughly detailed.
- Contamination Control: Demonstrate strong foundational knowledge of contamination control principles, contributing to the identification and control of potential risks within the cleanroom.
- cGMP Compliance: Follow all cGMP regulations, standard operating procedures (SOPs), and site-specific guidelines when conducting sampling, recording data, and handling samples.
- Cleanroom Practices: Consistently adhere to cleanroom gowning procedures, hygiene standards, and aseptic techniques, maintaining a high level of environmental cleanliness during all operations.
- Data Integrity: Accurately record all environmental monitoring data, ensuring documentation is complete, legible, and follows data integrity standards.
- Communication and Collaboration: Liaise effectively with other departments (production, QC, QA) to coordinate sampling activities and support investigations regarding out-of-specification or alert level events.
- Equipment Care: Maintain and calibrate environmental monitoring equipment according to SOPs.
- Continuous Improvement: Participate in ongoing environmental monitoring process improvement initiatives and training programs as the need arises.
Essential Skills And Qualifications
- Minimum College Level Diploma. Additional training in microbiology, environmental sciences, or contamination control is an asset.
- Experience working in a GMP cleanroom environment, especially with viable and particle sampling, is highly desirable.
- Strong understanding of contamination management, hygiene requirements for cleanroom, and general principles of microbiological and particulate monitoring.
- High attention to detail, ability to follow SOPs precisely, strong organizational skills, and effective communication.
- Personal Attributes: Reliability, accountability, and motivation to always uphold AstraZeneca’s quality and safety standards.
- Willingness and ability to work shifts, weekends, or holidays as needed. Occasional after-hours support for investigations, equipment alarms, or urgent testing.
- On-site presence in Hamilton, Ontario in classified areas, including work in isolators/hot cells with appropriate PPE and radiation safety protocols
- <5% travel required