Quality Engineer I

Job description

Position Summary

Position Summary: Perform microbiological testing for filter manufacturing processes and products, including environmental and water monitoring, microbial limit and bacterial challenge testing. Document test activities and results in accordance with GMP and data integrity principles.

Essential Functions

Perform filter release testing, including conductivity, TOC, Endotoxin, Diffusional Flow, and Bubble Point. Conduct environmental and water monitoring to verify the cleanliness control status in manufacturing and testing areas. Perform or support customer-requested microbiological or quality-related testing for filter products. Perform bacterial challenge testing as part of customer validation activities for filter products.

Perform QC microbiology testing and accurately document test data, raw data, test reports, logbooks, and records in accordance with GMP and data integrity requirements Qualifications Job Requirements : Bachelor’s degree or higher in Microbiology or a closely related field Minimum of 5 years of experience in microbiology QC within GMP-regulated pharmaceutical or filter manufacturing industries Experience performing or supporting bacterial challenge testing for filter products.

Ability to perform QC microbiology testing and accurately document test data, raw data, and test results in accordance with GMP and data integrity requirements. Ability to read English technical documents and communicate with global quality organizations.

Additional Comments

The essential functions have been provided as examples of the type of work performed by employees assigned to this job classification. The Company reserves the right to modify the work assignments and/or to make reasonable accommodations so that qualified employees can perform the essential functions. The job description is not intended to be an all inclusive list of duties and responsibilities. It is intended to describe the general nature of the position.