Microbiologist

Catalent Pharma Solutions•Winchester, KY

1d•Onsite

About The Position

Microbiologist Position Summary Typical working hours will be Monday-Friday 3 PM - 11:30 PM. This position is 100% on-site in Winchester, Kentucky. Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Microbiologist is primarily responsible for performing complex, non-routine microbiological analyses. The Microbiologist maintains the microbial testing needed to support raw materials, finished goods and environmental monitoring for the facility.

Requirements

Bachelors Degree in Microbiology, Biology or Chemistry Required (Preferred in Microbiology or Biology).
Experience in a Microbiology Laboratory, Clinical or Chemical Manufacturing role (including internships and co-op experience) preferred.
Working knowledge of cGMP regulations.
Experience in the pharmaceutical industry or clinical microbiology preferred.
Ability to work well as part of a team.
Must wear safety glasses, or specified eye protection, in all designated areas.
Must follow any applicable plant safety requirements.
Must be fit-tested, trained and capable of wearing air purifying respirator.
Must be trained in plant hazardous material procedures.
Must be able to lift up to 20 lbs.

Nice To Haves

Experience in a Microbiology Laboratory, Clinical or Chemical Manufacturing role (including internships and co-op experience) preferred.
Experience in the pharmaceutical industry or clinical microbiology preferred.

Responsibilities

Perform efficient/reliable microbial testing in accordance with USP/NF/EP/JP or customer guidelines.
Typical testing may include microbial water analysis, chemical water analysis, product contact surface environmental monitoring, viable/nonviable air monitoring, and raw materials and finished goods Microbial Limits Tests.
Maintain accurate written records of all testing performed.
Accurately interpret and effectively communicate microbial results and issues.
Calibrate and maintain microbiology lab equipment.
Perform peer review of microbiology testing and write up.
Prepare and perform microbiological validation protocols and summary reports.
Lead investigations involving microbiological Out of Specification results.
Other duties as assigned.