Environmental Monitoring Specialist - Group Leader

Key Responsibilities

• Cook up daily EM team schedule and activities according to client quality, manufacturing, and operations needs (planned or emergent).
• Perform environmental monitoring (air, surface, and personnel) testing using aseptic technique and strict adherence to standard GMP operating procedures.
• Utilize electronic Laboratory Information Management System (eLIMS) to carefully document sampling results.
• Frequently practice aseptic clean-room gowning/de-gowning to enter sterile (ISO-8, ISO-7, ISO-5) manufacturing areas/laminar flow units that are routinely sampled.
• Test system gases, incoming gas dewars, and clean steam on respective weekly, monthly, and annual bases.
• Aid client microbiology team with analyzing trends in sampling data/results. Implement necessary changes and/or schedule confirmative re-testing of rooms/sample points in response to negative trends/results.
• Track equipment/room validations to ensure sampling/maintenance schedules align with client demands and all equipment and materials being used in EM processes are within regulations.
• Train new members of microbiology and EM teams (client/Eurofins personnel) on use of MAS-100 and MetOne (viable and nonviable) air samplers.

Qualifications

• Bachelor’s degree in chemistry, biology, or a related life sciences (preferred)
• 1-3 years of pharmaceutical manufacturing or quality control laboratory experience, prior leadership or team coordination a plus
• Strong organization, time-management, and communication skills
• Strong knowledge or experience working within cGMP guidelines, GDP (good documentation practices), and aseptic technique
• Previous leadership experience preferred
• Authorization to work in the US indefinitely without restriction or sponsorship