Environmental Monitoring Specialist - Group Leader

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.
• 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
• Position is full-time, Monday-Friday, generally 8 a.m. - 5 p.m ., weekend work might be expected. Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.
• Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Benefits

Additional Information

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.

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