Environmental Monitoring Specialist - Group Leader

Eurofins USA PSS Insourcing Solutions•Malvern, PA

1d•Onsite

About The Position

This Environmental Monitoring scientist role supports the client quality control department by coordinating EM team activities and performing EM sampling/testing of utilities within GMP manufacturing and QC areas. The focus is on maintaining accurate EM schedules, tracking equipment and room validations/releases, and maintaining clear lines of communication within the team and across various client departments.

Requirements

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

Nice To Haves

prior leadership or team coordination a plus
Previous leadership experience preferred

Responsibilities

Coordinate 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.
Assist 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.