Job Description

Job Title: Sterility Assurance Technician

Schedule: Night shift including weekends, 12-hour shifts on a 2-2-3 rotation. Must be flexible to accommodate additional work in extended hours and/or off-hour work.

(6PM-6AM) and weekends.

• Need to come in 8AM-5PM for training. Probably first two weeks, then switch to nights.

Key Responsibilities:

• Participate in qualification and validation activities related to bioburden control strategies for facilities and equipment.
• Execute routine sterility assurance activites
• Support media fill simulations and provide documentation to ensure compliance with regulatory guidelines.
• Analyze and interpret environmental monitoring data, identifying trends and potential risks to product quality.
• Collaborate with cross-functional teams to troubleshoot contamination events and recommend corrective actions.
• Maintain accurate records and ensure timely reporting of sterility assurance results.

Qualifications:

• Experience in qualification or validation activities supporting contamination control measures in manufacturing facilities or equipment.
• Comprehensive understanding of aseptic techniques, either through hands-on operational experience or involvement in media fill processes.
• Prior experience participating in media fill simulations in a regulated environment.
• Ability to work in a fast-paced environment with strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.

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