POSITION OBJECTIVE

Ensure compliance with regulations related to microbiological control within the industry and compliance with official procedures in the projects in which the position participates and in the duties inherent to the role.

KEY RESPONSIBILITIES: 

• Identify appropriate microbiological controls and ensure they are implemented in projects where required, for example: product/process improvements and new product development/introduction projects.
   
• Design validation protocols related to Microbiology Laboratory methods or critical systems (HVAC, RODI, compressed air) and manage the resources needed to ensure proper and timely execution.
   
• Perform the periodic reviews required by Microbiology procedures (for example: annual reviews such as ISO class compliance, bioburden, sterilization, endotoxin, etc., and recalculation of alert/action limits for environmental testing). Ensure changes to procedures are implemented as a result of such reviews or recalculations.
   
• Identify and implement improvements in Microbiology procedures, for example through gap analyses of applicable standards or regulations.
   
• Review and approve “Further Investigations” related to complaints assigned to the Microbiology area.
   
• Ensure proper (re)qualification of equipment and provide technical support for the execution of sterilization cycle validations and sterilizer qualification through the review of protocols and reports.
   
• Ensure the availability of biological indicators (and related supplies) and assess their proper use in process validations or other required activities.
• Conduct root cause investigations for events related to Microbiology validations (including sterilization cycles) or Critical Systems and implement actions to resolve them.

• Ensure compliance with corporate and legal EHS requirements by adhering to internal policies and procedures. Likewise, ensure compliance through the adoption of strategies, internal controls, communication, and necessary training.
   
• Continuously improve EHS results through leadership, commitment, and active participation in all EHS-related initiatives.
   
• Perform all other duties inherent to the position and those assigned by the immediate supervisor.