Environmental Monitoring Specialist

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.

Key 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.

Qualifications :

• Bachelors 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
• Authorization to work in the US indefinitely without restriction or sponsorship

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time