Orano Med is seeking a Sterility Assurance Technician.

The technician will be responsible for conducting routine viable and non-viable environmental monitoring, sampling, and testing. The ideal candidate will collaborate with cross-functional teams to execute bioburden reduction monitoring strategies, evaluation of monitoring data, and assist in identifying and evaluating microbiology-related issues.

Technical Expertise

• 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.
• Ability to confidently interact with regulatory bodies (such as the FDA), notified bodies, and customers.
• Assist in responding to microbiology related requests and audit findings.

Risk Assessment and Root Cause Analysis

• 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.

Compliance & Standards

• Maintain compliance with relevant regulations (e.g. 21 CFR Part 210/211).
• Ensure adherence to industry standards and best practices.
• Collaborate with internal and external stakeholders to align processes with guidelines.

Quality Control & Audits

• Regularly audit personnel and processes for bioburden control and sterility assurance.

• Manage and evaluate ISO classification activities, media fills, and gowning qualification processes.

• Assist in trending and analysis of environmental monitoring and other microbiological data for management review and identification of continuous improvement opportunities.

Team Membership & Training

• Ability to adjust to unforeseen situations and provide recommendations as needed to achieve operational/business objectives.
• Assist in providing guidance, training, and support as needed to operators in support of as needed to operators in support of aseptic and sterile operations.
• Foster a culture of quality and compliance within the team.