Microbiologist

Catalent - Winchester, VA

Full-time - Entry Level

Winchester, VA

10,001+ employees

Chemical Manufacturing

About the position

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 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. The role involves performing efficient and 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. The Microbiologist must 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 prepare and perform microbiological validation protocols and summary reports. Additionally, the Microbiologist will lead investigations involving microbiological Out of Specification results and perform other duties as assigned.

Responsibilities

• Perform efficient/reliable microbial testing in accordance with USP/NF/EP/JP or customer guidelines.
• Conduct 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.
• Perform other duties as assigned.

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 understand and practice aseptic technique.
• Must be trained in plant hazardous material procedures.
• Must be able to lift up to 20 lbs.

Benefits

• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• Generous 401K match
• 19 days accrued PTO + 8 paid holidays