Environmental Monitoring Specialist

Job Description

Position Summary:

• This role is responsible for overseeing the Environmental Monitoring (EM) Program within an Advanced Cellular Therapeutics Facility.
• The individual will design, implement, and maintain a sustainable monitoring program to ensure compliance with quality and regulatory standards.
• The position requires collaboration with internal stakeholders and external vendors, along with independent decision-making to identify risks and improve processes.

Key Responsibilities:

Program Development & Implementation:

• Establish and implement the facility’s environmental monitoring program.
• Collaborate with third-party vendors to define best practices.
• Develop processes and schedules for ongoing monitoring activities.

Data Analysis & Reporting:

• Conduct environmental monitoring testing.
• Review, analyze, and trend environmental data.
• Provide regular reports on environmental status and emerging trends.

Quality & Compliance:

• Ensure adherence to Good Manufacturing Practices (GMP).
• Investigate environmental excursions and contamination events.
• Identify root causes and implement corrective actions.

Documentation & Training:

• Create and maintain technical documentation for the EM program.
• Train technicians on: Aseptic techniques
• Gowning procedures and qualifications

Continuous Improvement:

• Work independently to identify risks and improve monitoring processes.
• Develop and implement corrective and preventive actions (CAPA).

Required Qualifications:

• Bachelor’s degree (required).
• Knowledge of Microsoft Office (Word, Excel, PowerPoint).
• Understanding of Good Manufacturing Practices (GMP).

Preferred Qualifications:

• Minimum 3 years of experience in a GMP environment.
• Experience in environmental monitoring within manufacturing or laboratory settings.