Sterility Assurance Technician

Key Responsibilities

• Provide support in evaluating bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices.
• Perform routine environmental monitoring of controlled areas according to established Standard Operating Procedures (SOPs) and protocols.
• Collect and analyze samples for microbial enumeration and identification.
• Maintain proper documentation of all monitoring activities and results in accordance with Good Documentation Practices (GDP).
• Review and draft SOPs on an “as needed” basis.
• Collaborate with cross-functional teams to investigate and resolve quality events, deviations and non-conformances related to environmental monitoring.
• Assist in the validation and qualification of cleanroom facilities and equipment such as Media Fills or facility expansion projects.
• Stay updated on industry regulations and best practices to ensure compliance.
• Confidently interact with regulatory bodies (such as the FDA), notified bodies, and customers.
• Assist in responding to microbiology related requests and audit findings.
• Assist in gathering data and supporting documentation regarding microbiology or sterility assurance related investigations or risk assessments.
• Assist in root cause analyses for sterility assurance, environmental monitoring, and other microbiology-related issues.
• Assist in implementing corrective and preventive actions to address identified root causes and mitigate associated impact/risk assessments.
• Regularly audit personnel and processes for bioburden control and sterility assurance.
• Manage and evaluate ISO classification activities, media fills, and gowning qualification processes.
• Aid in trending and analysis of environmental monitoring and other microbiological data for management review and identification of continuous improvement opportunities.

Qualifications

• Education: Bachelor’s degree in microbiology, Biology, Molecular Cellular Biology or related field.
• Experience: Minimum of two (2) years of experience within the pharmaceutical or biotechnology industry. Two (2) years of industry experience should be focused on microbiology laboratory experience relating to environmental monitoring, microbiology laboratory operations, sterility assurance or related roles supporting current Good Manufacturing Practices (cGMP).
• Knowledge: Strong knowledge and experience with FDA regulations, United States Pharmacopeia (USP) guidance chapters and International Organization for Standardization (ISO) standards. Strong understanding of microbiological testing methods and quality control procedures.
• Skills: Excellent attention to detail, communication, organizational, and collaboration skills.