Careers with SCI
Sancilio & Company is currently looking to fill a Senior Microbiologist position at its Riviera Beach, Florida facility. This role will primarily be responsible for independently testing in-process material; raw materials used in the manufacturing process at the site, as well as finished products for microbial limits and specific organisms per USP and FDA guidance. Also, he/she will perform environmental analysis and process water testing in accordance to USP and FDA guidance. He/she will be called upon as a subject matter expert in microbial testing and environmental monitoring.RESPONSIBILITIES:
Responsibilities for this position include, but are not limited to:
- Proficiency with aseptic technique, microbiology laboratory skills and generallaboratory 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 monitory, viable/nonviable air monitoring, and raw materials/finished goods microbial limits testing.
- Assist with regulatory and customer audits when Microbiology information is required
- Maintain accurate written records of all testing performed
- Accurately interpret and effectively communicate microbial results and issues
- Schedule daily tasks in an organized and efficient manner
- Calibrate and maintain microbiology lab equipment
- Review, revise and/or write microbiology test methods and SOPs
- Develop proficiency in standard operating practices and test methods
- 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
- Takes personal ownership in work and takes responsibility for all elements of their assignments
- In combination with other lab personnel, be responsible for a clean and safe working environment
- Hands on experience in regulatory audits and maintaining the microbiology laboratory according to current USP and FDA guidance
- Experienced in facility and equipment qualification in support of microbial limit testing
- Bachelor's degree in Microbiology, Biology or Chemistry (preferred in Microbiology or Biology)
- Work Experience - 0-5 years in a Microbiology Laboratory, Clinical or Chemical Manufacturing role
- Experience in the pharmaceutical industry or clinical microbiology preferred