Environmental Monitoring Technician

About the Role

Cellipont Bioservices is seeking an Environmental Monitoring Technician (EM Technician) to support its quality control department. This role is crucial for ensuring the safety and efficacy of biologic drug substance manufacturing, sterile finished drug product, and fill/finish operations. The ideal candidate will embrace the potential of translating client discoveries into patient cures and is eager to drive innovation.

Key Responsibilities

• Perform routine Environmental Monitoring of Grades A-D cleanroom environments, including sampling of viable surfaces, viable air, and non-viable particulates.
• Perform and assist with Environmental Monitoring Performance Qualifications (EMPQ) of cleanrooms.
• Perform and assist with EM sample enumerations.
• Accurately document sampling activities in compliance with Good Documentation Practices (GDP).
• Support gowning qualifications and aseptic process simulations (media fills).
• Respond to deviations and alert/action limit excursions, and perform preliminary investigations.
• Prepare and transport samples to the microbiology laboratory for incubation and analysis.
• Collaborate with manufacturing, quality assurance, and QC Microbiology teams to ensure compliance with GMP regulations.
• Assist with trending data and supporting routine EM reporting.
• Adhere to all safety and gowning procedures within classified cleanroom areas.
• Demonstrate flexibility to accommodate unique campaign requirements, which may include off-hour and weekend work.
• Perform other duties as assigned.

Requirements & Tech Stack

• Experience: 0-1 year in an environmental monitoring or cleanroom setting.
• Proficiency in following standard operating procedures (SOPs).
• Ability to document activities accurately and promptly.
• Comfort working in a highly controlled cleanroom environment for extended periods.
• 2nd shift availability (2:00 PM – 11:00 PM), Monday through Friday, with occasional weekend or holiday support.

Qualifications

• High School diploma or equivalent required.
• Associate's or Bachelor's degree in Microbiology, Biology, or related field preferred.
• Knowledge and ability to apply basic scientific and regulatory principles for operational and routine quality tasks.
• Experience within the biotech, pharmaceutical, or cell/gene therapy industries is ideal.