Job Description

Key Responsibilities:

• Participate in qualification and validation activities related to bioburden control strategies for facilities and equipment.
• Execute routine sterility assurance activities
• 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.
• Bachelor's degree in Microbiology, Biology, or a related field preferred, or equivalent work experience.

Schedule:

Night shift, 12-hour shifts on a rotation schedule. Must be flexible to accommodate additional work in extended hours and/or off-hour work.

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