Job Description

Job Summary

The Environmental Monitoring (EM) Core Technician is responsible for performing EM activities in support of GMP production and aseptic processing of clinical-grade products. This role also involves cleanroom maintenance, stocking, and set-up to ensure compliance with regulatory and quality standards.

Key Responsibilities

• Conduct environmental monitoring to support GMP manufacturing of viral therapies.
• Perform cell culture and product purification using aseptic techniques, as required.
• Coordinate EM equipment requirements with the QC EM team to support manufacturing processes.
• Draft, complete, and revise manufacturing documentation, including batch records and EM forms.
• Prepare buffers and components, including operating steam autoclaves.
• Operate manual, semi-automated, and automated equipment to support routine clinical production.
• Utilize environmental monitoring equipment such as Solair, ApexZ50, and active particle counters.

Skills & Qualifications

• Strong knowledge of aseptic techniques; experience with cell culture and serological methods preferred.
• Ability to pass Class 10,000 cleanroom gowning qualification.
• Proficiency in Microsoft Office and other relevant computer applications.
• Excellent organizational and recordkeeping skills; strong time management and ability to handle multiple projects.
• Effective written and verbal communication skills.
• Team-oriented with the ability to work independently and maintain a strong work ethic.

Job Tags

Similar Jobs