Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here [http://www.catalent.com/index.php/about-us/Catalent-Careers2]
Catalent's Winchester, Kentucky location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.
The Microbiologist is primarily responsible for performing complex, non-routine microbiological analyses, and therefore must be capable of recognizing the need for pathogen identification, solving microbiological system problems, and leading and completing microbial investigations related to the water system, environmental monitoring of production equipment and the air handling system. The work is hands on and maintains the microbial testing needed to support raw materials, finished goods and environmental monitoring for the facility.
Work hours: 2nd shift Monday - Friday 3 pm - 11:30 pm (Work week starts Monday)
* Proficiency with aseptic technique, microbiology laboratory skills and general laboratory safety.
* 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; Schedule daily tasks in an organized and efficient manner.
* Review, revise and/or write microbiology test methods and SOPs.
* 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.
* Assist in training Associate Microbiologists/ new Microbiologists on SOPs and test methods.
* In combination with other lab personnel, be responsible for a clean and safe working environment.
* Other duties as assigned.
Education or Equivalent:
* Bachelors Degree in Microbiology, Biology or Chemistry (Preferred in Microbiology or Biology) required
* Work Experience - 0+ years in a Microbiology Laboratory, Clinical or Chemical Manufacturing role (including internships and co-op experience).
* Attention to detail.
* Basic knowledge of lab safety and the ability to work safely with microorganisms.
* Working knowledge of aseptic technique and microbiology principles.
* General computer literacy including use of Microsoft Word and Excel.
* Accurately testing on the first attempt under pressure of production details.
* Experience in the pharmaceutical industry or clinical microbiology preferred.
* Ability to work well as part of a team.
* Ability to stand/sit for long periods of time.
* Data entry
* Input of test results, trending and generation of Certificates of Analysis.
* Laboratory Procedures
* Safely perform testing required by position and proper use of PPE.
* Knowledge of and proper use of equipment.
* Safely handling microorganisms and reagents.
* Regular cleaning of lab space as required.
* Understanding and proper practice of dress code for manufacturing area.
* Coordination with other laboratory personnel for maintaining safe environment
* Assisting with other personnel with lifting of all objects of greater than 20 lbs.
* Maintaining clean and orderly environment for laboratory operations.
* Use of autoclave and safe handling of autoclaved materials, reagents, microorganisms and other required equipment.
* Coordination in a laboratory setting
* Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking.
Catalent's standard leadership competencies
* Leads with Integrity and Respect
* Delivers Results
* Demonstrates Business Acumen
* Fosters Collaboration and Teamwork
* Champions Change
* Engages and Inspires
* Coaches and Develops
Why you should join Catalent:
* Medical, Dental, Vision and 401K are all offered from day one of employment
* 19 days of paid time off annually
* Potential for career growth within an expanding team
* Defined career path and annual performance review and feedback process
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers [http://www.catalent.com/careers] to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 [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.
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