Winchester, KY, 40392, USA
13 days ago
Microbiologist
**Microbiologist** **Position Summary** 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. Shift: 2nd (Monday-Friday 2 PM-10:30 PM) 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. **The Role** + 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. **The Candidate** + 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. **Why You Should Join Catalent** + Several Employee Resource Groups focusing on D&I + Tuition Reimbursement – Let us help you finish your degree or earn a new one! + Generous 401K match + 152 hours accrued PTO + 8 paid holidays **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
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