Environmental Monitoring Specialist

Role: Environmental Monitoring Specialist

Location: San Diego, CA - 92121

Position Overview: We are seeking an Environmental Monitoring Specialist to help us refine and implement a comprehensive Environmental Monitoring (EM) process for our ISO 7 cleanroom during operational (dynamic) conditions. As we transition into the drug product market, compliance with multiple regulatory guidelines (such as USP, FDA, ICH, JP, EU, etc.) is critical. This role involves ensuring our EM program aligns with these standards, specifically for dynamic conditions, including setting up testing protocols, selecting test sites, establishing alert/action limits, and addressing any deviations from these limits.

Key Responsibilities

• Develop and implement a robust Environmental Monitoring program for dynamic conditions in an ISO 7 cleanroom.
• Ensure compliance with relevant regulatory frameworks for drug product facilities (USP, FDA, ICH, JP, EU, etc.).
• Define the frequency and scope of testing, including the number and location of test sites.
• Establish and maintain appropriate alert and action limits for monitoring results.
• Address and respond to any alert or action limit excursions, implementing corrective actions as needed.
• Collaborate with internal stakeholders to integrate EM processes into broader quality and compliance initiatives.
• Maintain accurate records and documentation to support regulatory audits and inspections.