Environmental Monitoring Analyst 3020650

📢 Now Hiring: Environmental Monitoring Analyst

📍 Location: Mount Sterling, KY

🕒 Shift: Saturday–Monday (6 AM – 6 PM) + Biweekly Tuesday (6 AM – 2:30 PM)

Our client, a leading biotech contract development and manufacturing organization (CDMO), is seeking an Environmental Monitoring Analyst to support Phase I/II GMP manufacturing. This role involves environmental monitoring, aseptic monitoring, and microbiological testing in a fast-paced quality control environment for the production of biologic bulk drug substances and sterile finished products.

Key Responsibilities:

✔ Environmental Monitoring (EM) in classified cleanrooms (ISO 5, 7, and 8), including surface and air sampling.

✔ Testing of utilities such as USP water, clean steam, and other manufacturing environments.

✔ Supporting media fills and fill/finish operations by monitoring air quality, personnel aseptic techniques, and environmental integrity.

✔ Acting as a Quality Control authority for aseptic flow and behavior in cleanrooms.

✔ Utilizing MODA for data entry, compilation, and trending of environmental data.

✔ Collaborating with Manufacturing and Quality Assurance teams to resolve quality issues.

✔ Performing bioburden and membrane filtration testing on cleaning, in-process, and release samples (if required).

✔ Adhering to cGMP and regulatory standards to ensure compliance.

Qualifications & Experience:

✔ Associate’s degree in Life Sciences and 2+ years of relevant experience in cGMP cleanrooms.

✔ Experience in cGMP Quality Control within a pharmaceutical or biotech environment.

✔ Strong attention to detail and ability to follow Good Manufacturing Practices (cGMPs).

✔ Proficiency in Microsoft Excel & Word.

✔ Experience with LIMS or MODA (preferred).

✔ Knowledge of bioburden and membrane filtration testing (a plus).

✔ Flexibility to work off-hours or weekends as required.

This is an excellent opportunity to advance your career in a growing biotech environment! If you meet the qualifications and are ready to contribute to a high-quality GMP manufacturing team, we encourage you to apply inside the job description today with an updated resume. 🚀

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